Ibuprofen IBUPROFEN AAA PHARMACEUTICAL, INC. FDA Approved Uses temporarily relieves minor aches and pains due to: headache backache the common cold minor pain of arthritis toothache menstrual cramps muscular aches temporarily reduces fever
FunFoxMeds bottle
Substance Ibuprofen
Route
ORAL
Applications
ANDA079129

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each caplet) Ibuprofen USP 200 mg (NSAID nonsteroidal anti-inflammatory drug )
Inactive Ingredients
Inactive ingredients colloidal silicon dioxide corn starch dextrose monohydrate hypromellose iron oxide red lactose monohydrate lecithin magnesium stearate maltodextrin microcrystalline cellulose povidone K30 pregelatinized starch sodium carboxymellose sodium starch glycolate stearic acid talc titanium dioxide triacetin
Strengths
200 mg
Quantities
100 tablet
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pains Due To Headache Backache The Common Cold Minor Pain Of Arthritis Toothache Menstrual Cramps Muscular Aches Temporarily Reduces Fever
Pill Appearance
Shape: oval Color: brown Imprint: IBU;200

Identifiers & Packaging

Container Type BOTTLE
UNII
WK2XYI10QM
Packaging

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton RESTORE u NDC 57344-110-03 †COMPARE TO THE ACTIVE INGREDIENT IN ADVIL ® Ibuprofen Tablets, USP 200 mg Pain Reliever, Fever Reducer (NSAID) 100 COATED CAPLETS** (**capsule-shaped tablets) Principal Display Panel - 100 Tablet Bottle Carton

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton RESTORE u NDC 57344-110-03 †COMPARE TO THE ACTIVE INGREDIENT IN ADVIL ® Ibuprofen Tablets, USP 200 mg Pain Reliever, Fever Reducer (NSAID) 100 COATED CAPLETS** (**capsule-shaped tablets) Principal Display Panel - 100 Tablet Bottle Carton

Overview

Uses temporarily relieves minor aches and pains due to: headache backache the common cold minor pain of arthritis toothache menstrual cramps muscular aches temporarily reduces fever

Indications & Usage

Uses temporarily relieves minor aches and pains due to: headache backache the common cold minor pain of arthritis toothache menstrual cramps muscular aches temporarily reduces fever

Dosage & Administration

Directions do not take more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings ) adults and children 12 years and over take 1 caplet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 caplet, 2 caplets may be used do not exceed 6 caplets 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 shock facial swelling skin reddening asthma (wheezing) 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 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 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 stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma you are taking a diuretic Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin 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 side effects occur. You may report side effects to FDA at 1-800-FDA-1088. you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools 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. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Purpose

Purpose Pain reliever/fever reducer

Do Not Use

Do not use if you have ever had an allergic reaction to 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 the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop Use & Ask a Doctor

Stop use and ask a doctor if side effects occur. You may report side effects to FDA at 1-800-FDA-1088. you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools 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

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.

Storage & Handling

Other information store between 20°-25°C (68°-77°F) avoid excessive heat above 40°C (104°F) read all warnings and directions before use retain carton for complete product information


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