The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Otc - Active Ingredient Section
Ibuprofen, USP 200 mg (NSAID)*____________________________________* nonsteroidal anti-inflammatory drug
Otc - Purpose Section
Pain reliever / fever reducer
Indications And Usage
■ temporarily relieves minor aches and pains due to: ■ headache ■ muscular aches ■ minor pain of arthritis ■ toothache ■ backache ■ the common cold ■ menstrual cramps■ temporarily reduces fever
- Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:hivesfacial swellingrashblistersshockskin reddeningasthma (wheezing)If an allergic reaction occurs, stop use and seek medical help right away.
Stomach Bleeding Warning
- This product contains a non-steroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding.The chance is higher if you: are age 60 or olderhave had stomach ulcers or bleeding problemstake a blood thinning (anticoagulant) or steroid drugtake other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)have 3 or more alcoholic drinks every day while using this producttake more or for a longer time than directed
Do Not Use
- If you have ever had an allergic reaction to any other pain reliever/fever reducerright before or after heart surgery
Ask A Doctor Before Use If
- You have problems or serious side effects from taking pain relievers or fever reducersthe stomach bleeding warning applies to youyou have a history of stomach problems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis, or kidney diseaseyou have asthmayou are taking a diuretic
Ask A Doctor Or Pharmacist Before Use If You Are
- Taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirinunder a doctor's care for any serious conditiontaking any other drug
When Using This Product
- Take with food or milk if stomach upset occursthe risk of heart attack or stroke may increase if you use more than directed or for longer than directed
Stop Use And Ask A Doctor If
■ you experience any of the following signs of stomach bleeding: ■ feel faint ■ vomit blood ■ have bloody or black stools ■ have stomach pain that does not get better■ pain gets worse or lasts more than 10 days■ fever gets worse or lasts more than 3 days■ redness or swelling is present in the painful area ■ any new symptoms appear
If Pregnant Or Breast-Feeding,
Ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Otc - Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Dosage And Administration
- Do not take more than directedthe smallest effective dose should be used adults and children 12 years and older ■ take 1 tablet every 4 to 6 hours while symptoms persist ■ if pain or fever does not respond to 1 tablet, 2 tablets may be used ■ do not exceed 6 tablets in 24 hours, unless directed by a doctor children under 12 years ■ ask a doctor
Storage And Handling
■ Store between 20-25°C (68-77°F)■ tamper evident: do not use if imprinted safety seal under cap is broken or missing; do not use if seal is open or missing in bulk pack.
Colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, red iron oxide, sodium starch glycolate, titanium dioxide, triacetin and talc
Otc - Questions
Call 1-732-465-0700: weekdays 8.00 AM to 8.00 PM
Manufactured by:Strides Pharma Science LimitedPuducherry - 605014, IndiaSee New Warnings InformationIbuprofen Tablets USP 200 mgPain Reliever / Fever Reducer (NSAID)- 30000 coated tablets
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