Leocillin may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Penethamate Hydriodide is reported as an ingredient of Leocillin in the following countries:
International Drug Name Search
Paroxetine ratiopharm may be available in the countries listed below.
Paroxetine is reported as an ingredient of Paroxetine ratiopharm in the following countries:
Paroxetine hydrochloride (a derivative of Paroxetine) is reported as an ingredient of Paroxetine ratiopharm in the following countries:
International Drug Name Search
Amoxicilina/Ácido Clavulánico may be available in the countries listed below.
Amoxicillin is reported as an ingredient of Amoxicilina/Ácido Clavulánico in the following countries:
Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Amoxicilina/Ácido Clavulánico in the following countries:
Clavulanic Acid is reported as an ingredient of Amoxicilina/Ácido Clavulánico in the following countries:
Clavulanic Acid potassium (a derivative of Clavulanic Acid) is reported as an ingredient of Amoxicilina/Ácido Clavulánico in the following countries:
International Drug Name Search
Nystat may be available in the countries listed below.
Nystatin is reported as an ingredient of Nystat in the following countries:
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Cronodine may be available in the countries listed below.
Diltiazem hydrochloride (a derivative of Diltiazem) is reported as an ingredient of Cronodine in the following countries:
International Drug Name Search
Atorvik-EZ may be available in the countries listed below.
Atorvastatin is reported as an ingredient of Atorvik-EZ in the following countries:
Ezetimibe is reported as an ingredient of Atorvik-EZ in the following countries:
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Gen-Paroxetine may be available in the countries listed below.
Paroxetine hydrochloride (a derivative of Paroxetine) is reported as an ingredient of Gen-Paroxetine in the following countries:
International Drug Name Search
Ambroxol Cinfa may be available in the countries listed below.
Ambroxol is reported as an ingredient of Ambroxol Cinfa in the following countries:
Ambroxol hydrochloride (a derivative of Ambroxol) is reported as an ingredient of Ambroxol Cinfa in the following countries:
International Drug Name Search
Generic Name: acetaminophen and tramadol (a SEET a MIN o fen and TRAM a dol)
Brand Names: Ultracet
Tramadol is a narcotic-like pain reliever. Acetaminophen is a less potent pain reliever that increases the effects of tramadol.
The combination of acetaminophen and tramadol is used to treat moderate to severe pain.
Acetaminophen and tramadol may also be used for purposes not listed in this medication guide.
alcohol;
tramadol (Ultram) or narcotic pain medicine;
sedatives or tranquilizers (such as Valium);
medicine for depression or anxiety;
medicine for mental illness (such as bipolar disorder, schizophrenia); or
street drugs.
Seizures have occurred in some people taking acetaminophen and tramadol. Your risk of a seizure may be higher if you have any of these conditions:
a history of drug or alcohol addiction;
a history of epilepsy or other seizure disorder;
a history of head injury;
a metabolic disorder;
an infection of your brain or spinal cord, such as meningitis or encephalitis;
if you are also taking an antidepressant, mood stabilizer, or another narcotic pain medicine; or
if you have taken an MAO inhibitor such as isocarboxazid (Marplan), linezolid (Zyvox), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days.
Talk with your doctor about your individual risk of having a seizure.
To make sure you can safely take acetaminophen and tramadol, tell your doctor if you have any of these other conditions:
kidney disease;
liver disease;
asthma or other breathing disorder;
a stomach disorder; or
a history of depression, mental illness, or suicide attempt.
The maximum amount of acetaminophen and tramadol is 2 tablets per dose, or 8 tablets per day. Acetaminophen and tramadol should not be used for longer than 5 days in a row.
Acetaminophen and tramadol can be taken with or without food, but take it the same way each time.
See also: Acetaminophen and tramadol dosage (in more detail)
Since pain medicine is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.
Overdose symptoms may also include drowsiness, shallow breathing, slow heartbeat, extreme weakness, sweating, cold or clammy skin, feeling light-headed, fainting, seizure, or coma.
seizure (convulsions);
agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting;
a red, blistering, peeling skin rash; or
shallow breathing, weak pulse.
Less serious side effects may include:
dizziness, drowsiness, weakness, tired feeling;
stomach pain, constipation, loss of appetite;
dry mouth, blurred vision;
feeling nervous or anxious;
sweating, itching; or
sleep problems (insomnia).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Usual Adult Dose for Pain:
Short term management of acute pain (5 days or less): 2 tablets every 4 to 6 hours as needed for pain.
Maximum dose: 8 tablets per day.
Usual Geriatric Dose for Pain:
Short term management of acute pain (5 days or less): 2 tablets every 4 to 6 hours as needed for pain.
Maximum dose: 8 tablets per day.
The following drugs can interact with acetaminophen and tramadol. Tell your doctor if you are using any of these:
carbamazepine (Carbatrol, Equetro, Tegretol);
warfarin (Coumadin, Jantoven);
digoxin (Lanoxin, Lanoxicaps);
ketoconazole (Nizoral);
erythromycin (E-Mycin, E.E.S., Ery-Tab);
rifampin (Rifadin, Rimactane, Rifater);
quinidine (Quin-G);
St. John's wort;
sumatriptan (Imitrex, Treximet) and other migraine headache medicines;
an antidepressant such as amitriptyline (Elavil), citalopram (Celexa), desipramine (Norpramin), fluoxetine (Prozac, Sarafem), imipramine (Tofranil), nortriptyline (Pamelor), paroxetine (Paxil), or sertraline (Zoloft); or
drugs to treat high blood pressure or a prostate disorder, such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), terazosin (Hytrin), tamsulosin (Flomax).
This list is not complete and other drugs may interact with acetaminophen and tramadol. Tell your doctor about all medications you use. This includes prescription, over the counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
Thrombin I may be available in the countries listed below.
Thrombin is reported as an ingredient of Thrombin I in the following countries:
International Drug Name Search
Ateroid may be available in the countries listed below.
Chondroitin Polysulfate is reported as an ingredient of Ateroid in the following countries:
International Drug Name Search
Generic Name: acetaminophen and diphenhydramine (a SEET a MIN oh fen and DYE fen HYE dra meen)
Brand Names: Anacin P.M. Aspirin Free, Coricidin Night Time Cold Relief, Excedrin PM, Excedrin PM Caplet, Excedrin PM Express Gels, Headache Relief PM, Legatrin PM, Mapap PM, Midol PM, Night Time Pain, Percogesic Extra Strength, Percogesic Original Strength, Tylenol Cold Relief Caplet, Tylenol Cold Relief Nighttime, Tylenol Cold Relief Nighttime Caplet, Tylenol Extra Strength PM, Tylenol Extra Strength PM Rapid Release Gelcaps, Tylenol Extra Strength PM Vanilla Caplet, Tylenol PM, Tylenol Sore Throat Nighttime, Unisom with Pain Relief
Acetaminophen is a pain reliever and fever reducer.
Diphenhydramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.
The combination of acetaminophen and diphenhydramine is used to treat headache, fever, body aches, runny or stuffy nose, sneezing, itching, watery eyes, and sinus congestion caused by allergies, the common cold, or the flu.
Acetaminophen and diphenhydramine may also be used for purposes not listed in this medication guide.
Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:
liver disease, cirrhosis, or a history of alcoholism;
a blockage in your digestive tract (stomach or intestines);
kidney disease;
cough with mucus, or cough caused by smoking, emphysema, or chronic bronchitis;
enlarged prostate or urination problems;
low blood pressure; or
if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).
Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. This medicine is usually taken only for a short time until your symptoms clear up.
Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
Do not take for longer than 7 days in a row. Stop taking the medicine and call your doctor if you still have a fever after 3 days of use, you still have pain after 7 days (or 5 days if treating a child), if your symptoms get worse, or if you have a skin rash, ongoing headache, or any redness or swelling.
Since this medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.
Overdose symptoms may also include severe forms of some of the side effects listed in this medication guide.
chest pain, rapid pulse, fast or uneven heart rate;
confusion, hallucinations, severe nervousness;
tremor, seizure (convulsions);
easy bruising or bleeding, unusual weakness;
urinating less than usual or not at all; or
nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes).
Less serious side effects may include:
dizziness, drowsiness;
mild headache;
dry mouth, nose, or throat;
constipation;
blurred vision;
feeling nervous; or
sleep problems (insomnia);
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Tell your doctor about all other medicines you use, especially:
leflunomide (Arava);
topiramate (Topamax);
zonisamide (Zonegran);
diphenhydramine (Benadryl) applied to the skin;
an antibiotic, antifungal medicine, sulfa drug, or tuberculosis medicine;
an antidepressant;
birth control pills or hormone replacement therapy;
bladder or urinary medications;
blood pressure medication;
a bronchodilator;
cancer medicine;
cholesterol-lowering medications such as Lipitor, Niaspan, Zocor, Vytorin, and others;
gout or arthritis medications (including gold injections);
HIV/AIDS medication;
medication for nausea and vomiting, stomach ulcers, or irritable bowel syndrome;
medicines to treat psychiatric disorders;
an NSAID such as Advil, Aleve, Arthrotec, Cataflam, Celebrex, Indocin, Motrin, Naprosyn, Treximet, Voltaren, others; or
seizure medication.
This list is not complete and other drugs may interact with acetaminophen and diphenhydramine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
See also: Tylenol Extra Strength PM side effects (in more detail)
In some countries, this medicine may only be approved for veterinary use.
USAN
0007758-02-3
K-Br
119
Antiepileptic agent
International Drug Name Search
Glossary
| JAN | Japanese Accepted Name |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| USAN | United States Adopted Name |
Aromek may be available in the countries listed below.
Letrozole is reported as an ingredient of Aromek in the following countries:
International Drug Name Search
Canesten Bifonazol may be available in the countries listed below.
Bifonazole is reported as an ingredient of Canesten Bifonazol in the following countries:
International Drug Name Search
Arteriol may be available in the countries listed below.
Buflomedil hydrochloride (a derivative of Buflomedil) is reported as an ingredient of Arteriol in the following countries:
International Drug Name Search
Sanigermin may be available in the countries listed below.
Triclosan is reported as an ingredient of Sanigermin in the following countries:
International Drug Name Search
In some countries, this medicine may only be approved for veterinary use.
Rec.INN
0000098-50-0
C6-H8-As-N-O3
217
Antibacterial
Arsonic acid, (4-aminophenyl)-
International Drug Name Search
Glossary
| BAN | British Approved Name |
| DCF | Dénomination Commune Française |
| IUPAC | International Union of Pure and Applied Chemistry |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
| WHO | World Health Organization |
Anzo may be available in the countries listed below.
Lansoprazole is reported as an ingredient of Anzo in the following countries:
International Drug Name Search
Arotinoil may be available in the countries listed below.
Arotinolol hydrochloride (a derivative of Arotinolol) is reported as an ingredient of Arotinoil in the following countries:
International Drug Name Search
Nitroglycerin is reported as an ingredient of Nitroglycerin Injection in the following countries:
International Drug Name Search
Calcium Carbonate is reported as an ingredient of Tums E-X in the following countries:
International Drug Name Search
Aroxin may be available in the countries listed below.
Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Aroxin in the following countries:
International Drug Name Search
Generic Name: carbetapentane and pseudoephedrine (kar BAY ta PEN tane and SOO doe ee FED rin)
Brand Names: Allres Pd, Carb Pseudo-Tan, Corzall, Pseudacarb, Re-Tann, Respi-TANN, Respi-Tann Pd
Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).
Carbetapentane is a cough suppressant. It affects the signals in the brain that trigger cough reflex.
The combination of carbetapentane and pseudoephedrine is used to treat cough and nasal and sinus congestion caused by the common cold, flu, or bronchitis.
Carbetapentane and pseudoephedrine may also be used for purposes not listed in this medication guide.
To make sure you can safely take carbetapentane and pseudoephedrine, tell your doctor if you have any of these other conditions:
heart disease or high blood pressure;
a seizure disorder;
glaucoma;
an enlarged prostate or problems with urination;
diabetes; or
a thyroid disorder.
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
The chewable tablet must be chewed before you swallow it.
If you need surgery, tell the surgeon ahead of time if you have taken a cough or cold medicine within the past few days.
Since cough or cold medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Avoid taking this medication if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.
fast, pounding, or uneven heartbeat;
severe dizziness, anxiety, restless feeling, or nervousness;
confusion, hallucinations;
slow, shallow breathing;
easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or
dangerously high blood pressure (severe headache, blurred vision, ringing in your ears, anxiety, confusion, chest pain, trouble breathing, uneven heart rate, seizure).
Less serious side effects may include:
loss of appetite, upset stomach;
warmth, redness, or tingling under your skin;
feeling excited or restless;
sleep problems (insomnia); or
mild skin rash or itching.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Tell your doctor about all other medicines you use, especially:
celecoxib (Celebrex);
cinacalcet (Sensipar);
darifenacin (Enablex);
imatinib (Gleevec);
quinidine (Quin-G);
ranolazine (Ranexa)
ritonavir (Norvir, Kaletra);
sibutramine (Meridia);
terbinafine (Lamisil);
medicines to treat high blood pressure;
an antidepressant such as amitriptyline (Elavil, Vanatrip), bupropion (Wellbutrin, Zyban), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Janimine, Tofranil), paroxetine (Paxil), sertraline (Zoloft), and others; or
a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others.
This list is not complete and other drugs may interact with carbetapentane and pseudoephedrine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
See also: Allres Pd side effects (in more detail)
Arolef may be available in the countries listed below.
Leflunomide is reported as an ingredient of Arolef in the following countries:
International Drug Name Search
Arteolol may be available in the countries listed below.
Carteolol hydrochloride (a derivative of Carteolol) is reported as an ingredient of Arteolol in the following countries:
International Drug Name Search
Nemexin may be available in the countries listed below.
Naltrexone hydrochloride (a derivative of Naltrexone) is reported as an ingredient of Nemexin in the following countries:
International Drug Name Search
Quintor may be available in the countries listed below.
Ciprofloxacin is reported as an ingredient of Quintor in the following countries:
International Drug Name Search
Arostowa may be available in the countries listed below.
Afloqualone is reported as an ingredient of Arostowa in the following countries:
International Drug Name Search
Atorvastatina Genfar may be available in the countries listed below.
Atorvastatin is reported as an ingredient of Atorvastatina Genfar in the following countries:
International Drug Name Search
Enemaster may be available in the countries listed below.
Barium Sulfate is reported as an ingredient of Enemaster in the following countries:
International Drug Name Search
Ido-E may be available in the countries listed below.
Tocopherol, α- acetate (a derivative of Tocopherol, α-) is reported as an ingredient of Ido-E in the following countries:
International Drug Name Search
Atorlip may be available in the countries listed below.
Atorvastatin is reported as an ingredient of Atorlip in the following countries:
Atorvastatin calcium (a derivative of Atorvastatin) is reported as an ingredient of Atorlip in the following countries:
International Drug Name Search
Arrow Lisinopril may be available in the countries listed below.
Lisinopril dihydrate (a derivative of Lisinopril) is reported as an ingredient of Arrow Lisinopril in the following countries:
International Drug Name Search
Arotin may be available in the countries listed below.
Paroxetine hydrochloride (a derivative of Paroxetine) is reported as an ingredient of Arotin in the following countries:
International Drug Name Search
CellCept Solution weakens your immune system, which may decrease your ability to fight illness or infection. It may also increase the risk of certain types of cancer (eg, lymphoma). Use CellCept Solution only under close medical supervision.
CellCept Solution may cause birth defects or fetal death if taken during pregnancy. Women who may become pregnant must use an effective form of birth control while they are taking CellCept Solution.
Preventing organ rejection following kidney, liver, or heart transplants. CellCept Solution is used in combination with other medicines. It may also be used for other conditions as determined by your doctor.
CellCept Solution is an immunosuppressant. It works by decreasing the activity of certain cells that make up part of the immune system to help reduce the risk of organ transplant rejection.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with CellCept Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with CellCept Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if CellCept Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use CellCept Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use CellCept Solution.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Anxiety; back pain; constipation; cough; diarrhea; dizziness; headache; loss of appetite; mild stomach pain; mild tiredness or weakness; nausea; pain, redness, or swelling at the injection site; tremor; trouble sleeping; upset stomach; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; bloody or black stools; change in the amount of urine produced; chest pain or pounding in the chest; fainting; irregular heartbeat; mental or mood changes (eg, abnormal thinking); night sweats; numbness, tingling, or swelling of the arms, legs, hands, ankles, or feet; severe headache, dizziness, or blurred vision; severe vomiting or stomach pain; shortness of breath; sluggishness; swollen glands; symptoms of infection (eg, fever, chills, cough, sore throat); symptoms of urinary tract infection (eg, difficult, frequent, or painful urination; lower stomach or back pain); unusual bruising or bleeding; unusual skin lumps or growths; unusual tiredness or weakness; unusual weight loss; unusually pale skin; vomiting blood that looks like coffee grounds; white patches in the mouth or throat; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: CellCept side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include diarrhea; nausea; vomiting.
CellCept Solution is usually handled and stored by a health care provider. If you are using CellCept Solution at home, store CellCept Solution as directed by your pharmacist or health care provider. Keep CellCept Solution out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about CellCept Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Arophalm may be available in the countries listed below.
Etizolam is reported as an ingredient of Arophalm in the following countries:
International Drug Name Search
Sulpirol may be available in the countries listed below.
Sulpiride is reported as an ingredient of Sulpirol in the following countries:
International Drug Name Search
Biherpan may be available in the countries listed below.
Heparin sodium salt (a derivative of Heparin) is reported as an ingredient of Biherpan in the following countries:
Zinc Sulfate is reported as an ingredient of Biherpan in the following countries:
International Drug Name Search
Oxandrin may cause cysts filled with blood in the liver or spleen, or liver tumors that may be fatal. These side effects may go unnoticed until life-threatening liver failure or internal bleeding develops. These side effects often stop or reverse when the medicine is stopped. Oxandrin may also cause blood lipid (fat) changes that may increase the risk of hardening of the arteries and certain heart/blood vessel diseases (coronary artery disease).
Promoting weight gain, in combination with other medicines, after weight loss due to major surgery, recurring infections, serious injury, or unknown reasons. It is also used to offset certain side effects of long-term steroid use (protein catabolism), or to relieve bone pain due to osteoarthritis. It may also be used for other conditions as determined by your doctor.
Oxandrin is an anabolic steroid. It works by helping the body to produce testosterone, which helps build muscle mass.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Oxandrin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Oxandrin. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Oxandrin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Oxandrin as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Oxandrin.
When used for long periods of time or at high doses, some people develop a need to continue taking Oxandrin. This is known as DEPENDENCE or addiction.
If you suddenly stop taking Oxandrin, you may experience WITHDRAWAL symptoms, including depression, insomnia, loss of appetite, mood swings, reduced sex drive, restlessness, or tiredness.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Difficulty sleeping.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne; changes in sexual desire; changes in skin color; confusion; dark urine; deepening of the voice, unusual hair growth (especially facial hair), or hoarseness; depression; easy bruising or bleeding; enlarged genitals or breasts; excitability; frequent or persistent erections; increased urination or thirst; irregular heartbeat; loss of appetite; menstrual irregularities; mental or mood changes; muscle cramps or twitching; nausea or vomiting; stomach pain; swelling of the ankles or hands; unusual tiredness; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Oxandrin side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Store Oxandrin at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Oxandrin out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Oxandrin. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
| |||
| Each 1.0 mL supplies: | Percentage of U.S. Recommended Daily Allowance | ||
| Infants | Children Under 4 | ||
| Vitamin A | 1500 IU | 100 | 60 |
| Vitamin C | 35 mg | 100 | 88 |
| Vitamin D | 400 IU | 100 | 100 |
| Vitamin E | 5 IU | 100 | 50 |
| Thiamine | 0.5 mg | 100 | 71 |
| Riboflavin | 0.6 mg | 100 | 75 |
| Niacin | 8 mg | 100 | 89 |
| Vitamin B6 | 0.4 mg | 100 | 57 |
| Vitamin B12 | 2 mcg | 100 | 67 |
| Fluoride | 0.25 mg | * | * |
This product does not contain the essential vitamin folic acid.
See INDICATIONS AND USAGE section below for use by infants and young children 6 months to 3 years of age.
Active ingredient for caries prophylaxis: Fluoride as sodium fluoride.
Other Ingredients: Ascorbic acid, caramel color, cherry flavor, cholecalciferol, cyanocobalamin, ferrous sulfate, glycerin, methylparaben, niacinamide, oil of orange, polysorbate 80, purified water, pyridoxine hydrochloride, riboflavin-5-phosphate sodium, sodium benzoate, sodium hydroxide, thiamine hydrochloride, d-alpha tocopheryl acid succinate, vitamin A palmitate. Citric acid may be added to adjust pH.
It is well established that fluoridation of the water supply (1 ppm fluoride) during the period of tooth development leads to a significant decrease in the incidence of dental caries.
Hydroxyapatite is the principal crystal for all calcified tissue in the human body. The fluoride ion reacts with the hydroxyapatite in the tooth as it is formed to produce the more caries-resistant crystal, fluorapatite. The reaction may be expressed by the equation:1
Three stages of fluoride deposition in tooth enamel can be distinguished:1
Supplementation of the diet with nine essential vitamins.
Supplementation of the diet with fluoride for caries prophylaxis. The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation.
Multivitamin and Fluoride 0.25 mg drops provide fluoride in drop form for infants and young children 6 months to 3 years of age, in areas where the drinking water contains less than 0.3 ppm of fluoride and for children ages 3-6 years, in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride. Each 1.0 mL supplies sodium fluoride (0.25 mg fluoride) plus nine essential vitamins.
The American Academy of Pediatrics2 and the American Dental Association3 currently recommend that infants and young children 6 months to 3 years of age, in areas where drinking water contains less than 0.3 ppm of fluoride, and children 3-6, in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride, receive 0.25 mg of supplemental fluoride daily which is provided in a full dose (1 mL) of Multivitamin and Fluoride 0.25 mg drops. A half dose (0.5 mL) of Multivitamin and Fluoride Drops 0.5 mg drops could also provide a daily fluoride intake of 0.25 mg; however, this dosage reduces vitamin supplementation by half.
Multivitamin and Fluoride 0.25 mg and 0.5 mg drops supply significant amounts of vitamins A, C, D, E, thiamine, riboflavin, niacin, pyridoxine, and cyanocobalamin to supplement the diet, and to help assure that nutritional deficiences of these vitamins will not develop. Thus, in a single easy-to-use preparation, infants and children obtain nine essential vitamins and fluoride.
A comprehensive 5-1/2 year series of studies of the effectiveness of Tri-Vi-Flor® and Poly-Vi-Flor® products in caries protection has been published.4-7 Children in this continuing study lived in an area where the water supply contained only 0.05 ppm fluoride. The subjects were divided into two groups, one which used only non-fluoridated Vi-Sol® vitamin products and the other Tri-Vi-Flor® and Poly-Vi-Flor® vitamin-fluoride products.
The three-year interim report showed 63% fewer carious surfaces in primary teeth and 43% fewer carious surfaces in permanent teeth of the children taking Vi-Flor® vitamin-fluoride products.4
After four years the studies continued to support the effectiveness of Tri-Vi-Flor® and Poly-Vi-Flor®, showing a reduction in carious surfaces of 68% in primary teeth and 46% in permanent teeth.5 Results at the end of 5-1/2 years further confirmed the previous findings and indicated that significant reductions in dental caries are apparent with the continued use of Vi-Flor® vitamin-fluoride products.6
As in the case of all medications, keep out of reach of children.
The suggested dose should not be exceeded since dental fluorosis may result from continued ingestion of large amounts of fluoride. When prescribing vitamin fluoride products:
Multivitamin and Fluoride Drops 0.25 mg should be dispensed in the original plastic container, since contact with glass leads to instability and precipitation. (The amount of sodium fluoride in the 50-mL size is well below the maximum to be dispensed at one time according to recommendations of the American Dental Association.)
Allergic rash and other idiosyncrasies have been rarely reported.
To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010.
1.0 mL daily or as prescribed by physician. May be dropped directly into mouth with dropper; or mixed with cereal, fruit juice or other food.
Multivitamin and Fluoride 0.25 mg drops are available in 50 mL bottles with accompanying calibrated dropper.
Store at controlled room temperature, 15º-30ºC (59º-86ºF). After opening, store away from direct light. Close tightly after each use. Occasional deepening of color has no significant effect on vitamin potency.
REFRIGERATION IS NOT REQUIRED
Manufactured By:
HI-TECH PHARMACAL CO., INC.
Amityville, N.Y. 11701
Rev. 642:06 4/09
NDC 50383-642-50
Poly-Vitamin Drops
WITH FLUORIDE
0.25 mg
MULTIVITAMIN AND FLUORIDE SUPPLEMENT DROPS
Rx Only
1 2/3 FL. OZ. (50 mL)
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| Unapproved drug other | 07/01/1990 | 05/03/2012 | |
| Labeler - Hi-Tech Pharmacal Co., Inc. (101196749) |
