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Ibuprofen

Dosage form: tablet
Ingredients: IBUPROFEN 200mg
Labeler: Cardinal Health
NDC Code: 55154-5840

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Ibuprofen 200 mg

Active ingredient (in each tablet)

Ibuprofen USP 200mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

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.

This unit dose package is not child-resistant. If dispensed for outpatient use, a child-resistant container should be utilized.

Uses

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

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 and blisters.

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding The chance is higher if you: are age 60 or older, have had stomach ulcers or bleeding problems, if you take a blood thinning (anticoagulant) or steroid drug, if you take other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others), if you have 3 or more alcoholic drinks every day while using this product, or if you 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 or right before or after heart surgery.

Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers, if you have stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain, ulcers, bleeding problems, high blood pressure, heart or kidney disease, asthma, taken a diuretic or reached age 60 or older.

Ask a doctor or pharmacist before use if you are taking any other drug containing an NSAID (prescription or nonprescription), if you are taking a blood thinning (anticoagulant) or steroid drug, if you are under a doctor's care for any serious condition, if you are taking aspirin to prevent heart attack or stroke because ibuprofen may decrease this benefit of aspirin or if you are 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 you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding. Stop use and ask a doctor if pain gets worse or lasts more than 10 days, if fever gets gets worse or lasts more than 3 days, stomach pain or upset gets worse or lasts, if redness or swelling is present in the painful area or if 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.

TAMPER-EVIDENT: each tablet is individually sealed. Do not use if blister is torn or broken.

Directions

Read all warnings and directions before use.

  • 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 of age 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

Inactive ingredients

Acacia, calcium carbonate, carnauba wax, confectioner's sugar, crospovidone, gelatin, guar gum, hydrogenated vegetable oil, hydroxypropyl cellulose, kaolin, pharmaceutical ink, polyethylene glycol, powdered cellulose, pregelatinized starch, silicone dioxide, sodium benzoate, starch, sucrose, talc, titanium dioxide, white wax.

STORAGE:

Store at 20-25 C (68-77 F) avoid excessive heat above 40 C (104 F).

Manufactured for:

GOLDLINE LABORATORIES, INC

Sellersville, PA 18960

by: Ohm Laboratories, Inc.

North Brusnwick, NJ 08902

Questions? call 1-888-838-2872, weekdays, 8 AM - 5 PM Eastern Time

REPACKAGED BY Cardinal Health

Zanesville, OH 43701

Principal Display Panel

Ibuprofen, USP

200 mg

10 Tablets

IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-5840(NDC:0182-8688)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA 
CALCIUM CARBONATE 
CARNAUBA WAX 
SUCROSE 
CROSPOVIDONE 
GELATIN 
GUAR GUM 
HYDROGENATED CASTOR OIL 
HYDROXYPROPYL CELLULOSE 
KAOLIN 
POLYETHYLENE GLYCOLS 
POWDERED CELLULOSE 
STARCH, CORN 
SILICON DIOXIDE 
SODIUM BENZOATE 
STARCH, CORN 
SUCROSE 
TALC 
TITANIUM DIOXIDE 
WHITE WAX 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize10mm
FlavorImprint Code420
Contains    
Packaging
#Item CodePackage Description
1NDC:55154-5840-010 BLISTER PACK in 1 BAG
11 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other06/02/2011
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIOperations
Cardinal Health188557102REPACK(55154-5840)

Revised: 04/2012
 
Cardinal Health

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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