Ibuprofen IBUPROFEN CARDINAL HEALTH 107, LLC FDA Approved Uses ▪ temporarily relieves minor aches and pains due to: ▪ backache ▪ menstrual cramps ▪ toothache ▪ muscular aches ▪ headache ▪ the common cold ▪ minor pain of arthritis ▪ temporarily reduces fever
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Substance Ibuprofen
Route
ORAL
Applications
ANDA075139
Product NDC
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each white tablet) Ibuprofen USP 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive ingredients colloidal silicon dioxide corn starch hypromellose lactose anhydrous magnesium stearate microcrystalline cellulose polydextrose polyethylene glycol povidone sodium starch glycolate stearic acid triacetin
Strengths
200 mg
Quantities
10 tablets
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pains Due To Backache Menstrual Cramps Toothache Muscular Aches Headache The Common Cold Minor Pain Of Arthritis Temporarily Reduces Fever
Pill Appearance
Shape: round Color: white Imprint: 44;438

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UPC
0055154066907
UNII
WK2XYI10QM
Packaging

Principal Display Panel NDC 55154-0669-0 IBUPROFEN TABLETS, USP 200mg Pain Reliever/Fever Reducer (NSAID) 10 TABLETS 200mg bag label

Package Descriptions
  • Principal Display Panel NDC 55154-0669-0 IBUPROFEN TABLETS, USP 200mg Pain Reliever/Fever Reducer (NSAID) 10 TABLETS 200mg bag label

Overview

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

Indications & Usage

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

Warnings & Precautions
Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: ▪ rash ▪ facial swelling ▪ shock ▪ blisters ▪ skin reddening ▪ hives ▪ asthma (wheezing) 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 ▪ take more or for a longer time than directed ▪ take a blood thinning (anticoagulant) or steroid drug ▪ are age 60 or older ▪ have 3 or more alcoholic drinks every day while using this product ▪ take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] ▪ have had stomach ulcers or bleeding problems Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer 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 a history of stomach problems, such as heartburn ▪ you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke ▪ you are taking a diuretic ▪ you have problems or serious side effects from taking pain relievers or fever reducers 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 Stop use and ask a doctor if ▪ you experience any of the following signs of stomach bleeding: ▪ feel faint ▪ have bloody or black stools ▪ vomit blood ▪ have stomach pain that does not get better ▪ you have symptoms of heart problems or stroke: ▪ chest pain ▪ slurred speech ▪ leg swelling ▪ trouble breathing ▪ weakness in one part or side of body ▪ 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 at 20 weeks or later in 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

Stop Use & Ask a Doctor

Stop use and ask a doctor if ▪ you experience any of the following signs of stomach bleeding: ▪ feel faint ▪ have bloody or black stools ▪ vomit blood ▪ have stomach pain that does not get better ▪ you have symptoms of heart problems or stroke: ▪ chest pain ▪ slurred speech ▪ leg swelling ▪ trouble breathing ▪ weakness in one part or side of body ▪ 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) ▪ TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN ▪ avoid excessive heat 40°C (104°F) ▪ use by expiration date on package

Questions

Questions or comments? Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday


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