PAIN RELIEF- ibuprofen tablet

Pain Relief by

Drug Labeling and Warnings

Pain Relief by is a Otc medication manufactured, distributed, or labeled by Select Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Ibuprofen USP 200 mg

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 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

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.

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, olyvinyl alcohol, pregelatinized starch, talc, titanium dioxide.

PRINCIPAL DISPLAY PANEL

MM1

INGREDIENTS AND APPEARANCE

PAIN RELIEF  
ibuprofen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52904-447
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg

Inactive Ingredients
Ingredient Name	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TALC (UNII: 7SEV7J4R1U)
STARCH, CORN (UNII: O8232NY3SJ)
POLYVINYL ALCOHOL (UNII: 532B59J990)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	white (snow white)	Score	no score
Shape	ROUND (115)	Size	10mm
Flavor		Imprint Code	115
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52904-447-02	2 in 1 PACKET

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)