Pain Relief Anti Inflammatory
FDA Label NDC 52904-486

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Select Corporation for the product Pain Relief Anti Inflammatory (NDC 52904-486). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, dosage & administration, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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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