Ibuprofen 200mg IBUPROFEN SOUTHERN SALES & SERVICES, INC. FDA Approved 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
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Substance Ibuprofen
Route
ORAL
Applications
ANDA072096
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each tablet) Ibuprofen 200 mg (NSAID)* *nonsteroidal anti-inflammatory dru
Inactive Ingredients
Inactive ingredients colloidal silicon dioxide corn starch croscarmellose sodium hypromellose iron oxide red iron oxide yellow microcrystalline cellulose polyethylene glycol polysorbate 80 stearic acid titanium dioxide
Strengths
200 mg
Quantities
50 tablets
Treats Conditions
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
Pill Appearance
Shape: round Color: brown Imprint: I2

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
WK2XYI10QM
Packaging

Ibuprofen 200mg 50 Tablets Ibuprofen

Package Descriptions
  • Ibuprofen 200mg 50 Tablets Ibuprofen

Overview

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

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

Dosage & Administration

Directions do not take more than directed the 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

Warnings & Precautions
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 chances are 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 NSAIDs [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
Purpose

Purposes Pain reliever/fever reducer

Do Not Use

Don not use if you have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer right before or after heart surgery

When Using

When using this product take with food or milk if stomach upset occurs

Stop Use & Ask a Doctor

Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomitblood have bloody or black stools have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling 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

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away


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