Pain Relief: Package Insert and Label Information

PAIN RELIEF — ibuprofen tablet
Select Corporation

Active Ingredients

Pain reliever/fever reducer, nonsteroidal anti-inflammatory drug

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

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: Allergy alert: Ibuprofen may cause a severe 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 bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: • are age 60 or older • have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • take other drugs containing prescription or nonprescription NSAID’s (aspirin, ibuprofen, naproxen, or others) • have 3 or more alcoholic drinks every day while using this product • take 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 reducer • right before or after heart surgery Ask a doctor before use if • you have problems or serious side effects from taking pain relievers or fever reducers • the stomach bleeding warning applies to you • you have a history of stomach problems such as heartburn• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease • you have asthma • you 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 aspirin • under a doctor’s care for any serious condition • taking any other drug When using this product • take with food or milk if stomach upset occurs • the 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 • you 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.


Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, olyvinyl alcohol, pregelatinized starch, talc, titanium dioxide.


Pain Ibuprofen packet
(click image for full-size original)
ibuprofen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52904-447
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Inactive Ingredients
Ingredient Name Strength
Product Characteristics
Color white (snow white) Score no score
Shape ROUND (115) Size 10mm
Flavor Imprint Code 115
# Item Code Package Description Multilevel Packaging
1 NDC:52904-447-02 2 TABLET (TABLET) in 1 PACKET None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091239 10/15/2012
Labeler — Select Corporation (053805599)
Registrant — Select Corporation (053805599)

Revised: 10/2012 Select Corporation provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

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