Ibuprofen IBUPROFEN RETAIL BUSINESS SERVICES, LLC 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
ANDA079174

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each caplet) Ibuprofen 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive ingredients colloidal silicon dioxide iron oxide red maize starch polyethylene glycol povidone k-30 pregelatinized starch sodium starch glycolate stearic acid talc titanium dioxide
Strengths
200 mg
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: oval Color: brown Imprint: G2

Identifiers & Packaging

Container Type UNKNOWN
UNII
WK2XYI10QM
Packaging

Principal Display Panel 50ct; Principal Display Panel 100ct

Package Descriptions
  • Principal Display Panel 50ct
  • Principal Display Panel 100ct

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 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 ■ 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 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 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
Purpose

Purposes Pain reliever/ fever reducer

Do Not Use

Do 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 • vomit blood • 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 apprear

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. (1-800-222-1222)

Storage & Handling

Other information ■ store between 20-25°C (68-77°F). [See USP Controlled Room Temperature]. ■ avoid excessive heat above 40°C (104°F)

Questions

Questions or comments? call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST


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