Ibuprofen IBUPROFEN CHAIN DRUG MARKETING ASSOCIATION, INC. FDA Approved Uses temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis temporarily reduces fever
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Substance Ibuprofen
Route
ORAL
Applications
ANDA078682
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each capsule) Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)* (present as the free acid and potassium salt) *nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive ingredients FD&C Blue #1 gelatin pharmaceutical ink polyethylene glycol potassium hydroxide purified water sorbitan and sorbitol For India Manufacturing Site: FD&C Blue #1 gelatin polyethylene glycol potassium hydroxide purified water sorbitan and sorbitol
Strengths
200 mg
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pains Due To Headache Toothache Backache Menstrual Cramps The Common Cold Muscular Aches Minor Pain Of Arthritis Temporarily Reduces Fever
Pill Appearance
Shape: capsule Color: blue Imprint: IB1

Identifiers & Packaging

Container Type BOX
All Product Codes
UPC
0635515996762
UNII
WK2XYI10QM
Packaging

48's carton NDC 83324-206-48 QC ® QUALITY CHOICE † Compare to the Active Ingredient in Advil ® LIQUI-GELS ® Ibuprofen Ibuprofen Capsules, 200 mg Pain Reliever/Fever Reducer (NSAID) 20% More FREE actual size 48 Softgels** **Liquid Filled Capsules carton; 48's carton-Made In India label NDC 83324-206-48 QC ® QUALITY CHOICE † Compare to the Active Ingredient in Advil ® LIQUI-GELS ® Ibuprofen Capsules, 200 mg Pain Reliever/Fever Reducer (NSAID) 20% More FREE actual size 48 Softgels** **Liquid Filled Capsules 48-carton

Package Descriptions
  • 48's carton NDC 83324-206-48 QC ® QUALITY CHOICE † Compare to the Active Ingredient in Advil ® LIQUI-GELS ® Ibuprofen Ibuprofen Capsules, 200 mg Pain Reliever/Fever Reducer (NSAID) 20% More FREE actual size 48 Softgels** **Liquid Filled Capsules carton
  • 48's carton-Made In India label NDC 83324-206-48 QC ® QUALITY CHOICE † Compare to the Active Ingredient in Advil ® LIQUI-GELS ® Ibuprofen Capsules, 200 mg Pain Reliever/Fever Reducer (NSAID) 20% More FREE actual size 48 Softgels** **Liquid Filled Capsules 48-carton

Overview

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

Indications & Usage

Uses temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps the common cold muscular aches 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 capsule every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 capsule, 2 capsules may be used do not exceed 6 capsules 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 be fatal. The risk is higher if you use more than directed or for longer than directed.
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 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 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 each capsule contains: potassium 20 mg read all warnings and directions before use. Keep carton. store at 20° to 25°C (68° to 77°F) avoid excessive heat above 40°C (104°F). Protect from light.

Questions

Questions or comments? call toll free 1-888-235-2466 DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “ SEALED for YOUR PROTECTION ” IS BROKEN OR MISSING. READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION † All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Advil ® LIQUI-GELS ® . Distributed by C.D.M.A., Inc. Novi, MI 48375 www.qualitychoice.com Questions: 800-935-2362 L0000925 R1024 For India Manufacturing Site: MADE IN INDIA Code: TN/DRUGS/TN/25/00074 P3457/00/25 R0325 L0001019


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