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Ibuprofen Dye-Free by Wal-Mart Stores Inc

Medically reviewed on April 4, 2018

Dosage form: tablet, film coated
Ingredients: IBUPROFEN 200mg
Labeler: Wal-Mart Stores Inc
NDC Code: 49035-438

Equate 44-438

Active ingredients (in each white tablet)

Ibuprofen USP,
200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

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

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:

  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • are age 60 or older
  • 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
  • right before or after heart surgery
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer

Ask a doctor before use if
  • you have asthma
  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you are taking a diuretic
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • 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
  • 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 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
  • 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 (1-800-222-1222) right away.

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

Other information
  • store between 20ºC - 25ºC (68º - 77ºF)
  • avoid excessive heat 40ºC (104ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, triacetin

Questions or comments?

1-888-287-1915

Principal display panel

NDC 49035-438-12

equate™                                                               Compare to Advil® Tablets Active ingredient**

Dye-Free

Ibuprofen

Tablets, 200 mg

Pain Reliever/
Fever Reducer
(NSAID)

200 mg                  100 TABLETS                   Actual Size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Satisfaction guaranteed - Or we'll replace it or give you your money back. For questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915.

DISTRIBUTED BY: Wal-Mart Stores, Inc.,
Bentonville, AR 72716

**This product is not manufactured or distributed by Pfizer Inc., the maker of Advil®.
The trademark Advil® is owned by Wyeth LLC.
50844    REV0411A43812

Equate 44-438

IBUPROFEN  DYE-FREE
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-438
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYDEXTROSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POVIDONE 
STEARIC ACID 
TRIACETIN 
LACTOSE, UNSPECIFIED FORM 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
SILICON DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize10mm
FlavorImprint Code44;438
Contains    
Packaging
#Item CodePackage Description
1NDC:49035-438-121 BOTTLE in 1 CARTON
1100 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07513903/11/2004
Labeler - Wal-Mart Stores Inc (051957769)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(49035-438)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(49035-438)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(49035-438)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(49035-438)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(49035-438)

 
Wal-Mart Stores Inc

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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