FDA Label for Pain Relief Anti Inflammatory
View Indications, Usage & Precautions
Pain Relief Anti Inflammatory Product Label
The following document was submitted to the FDA by the labeler of this product Select Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredients Ibuprofen USP 200 mg
Otc - Purpose
Pain reliever/fever reducer nonsteroidal anti-inflammatory drug
Dosage & Administration
Directions: • do not take more than directed • the smallest effective dose should be used • adults and children 12 years and over: • 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
Indications & Usage
Uses • 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
Warnings
Warnings: Allergy alert: Ibuprofen may cause asevere allergic reaction, especially in people allergic to aspirin.Symptoms may include: • hives • facial swelling • asthma (wheezing)• shock • skin reddening • rash • blisters. If an allergic reaction occurs,stop use and seek medical help right away. Stomach bleedingwarning: This product contains an NSAID, which may cause severestomach bleeding. The chance is higher if you: • are age 60 or older •have had stomach ulcers or bleeding problems • take a bloodthinning (anticoagulant) or steroid drug • take other drugs containingprescription or nonprescription NSAID’s (aspirin, ibuprofen,naproxen, or others) • have 3 or more alcoholic drinks every day whileusing this product • take more or for a longer time than directed Donot use • if you have ever had an allergic reaction to any other painreliever/fever reducer • right before or after heart surgery Ask adoctor before use if • you have problems or serious side effects fromtaking pain relievers or fever reducers • the stomach bleedingwarning applies to you • you have a history of stomach problemssuch as heartburn• you have high blood pressure, heart disease, livercirrhosis, or kidney disease you have asthma • you are taking a diureticAsk a doctor or pharmacist before use if youare • taking aspirin for heart attack or stroke, becauseibuprofen may decrease this benefit of aspirin• under a doctor’s care for any serious condition • takingany other drug When using this product • take withfood or milk if stomach upset occurs • the risk of heartattack or stroke may increase if you use more than directedor for longer than directed Stop use and ask a doctor if • youexperience any of the following signs of stomach bleeding• feel faint • vomit blood • have bloody or black stools • youhave stomach pain that does not get better • pain gets worseor lasts more than 10 days • fever gets worse or lasts morethan 3 days • redness or swelling is present in the painful area• any new symptoms appear
Otc - Pregnancy Or Breast Feeding
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
KEEP OUT OF REACH OF CHILDREN.
Inactive Ingredient
Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide.
Package Label.Principal Display Panel
MM1
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