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Ibuprofen by WinCo Foods, LLC

Medically reviewed on Feb 5, 2018

Dosage form: tablet, coated
Ingredients: IBUPROFEN 200mg
Labeler: WinCo Foods, LLC
NDC Code: 67091-126

WNC - 1109 - 2015-0204

Drug Facts

Active ingredient (in each 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:

  • 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

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 problems or serious side effects from taking pain relievers or fever reducers
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma
  • you are taking a diuretic

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
  • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
  • 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
  • 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 right away.

Directions
  • 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 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 20°-25°C (68°-77°F)
  • avoid excessive heat above 40°C (104°F)
  • read all warnings and directions before use
  • retain carton for complete product information

Inactive ingredients

colloidal silicon dioxide, corn starch, dextrose monohydrate, hypromellose, iron oxide red, lactose monohydrate, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone K30, pregelatinized starch, sodium carboxymellose, sodium starch glycolate, stearic acid, talc, titanium dioxide, triacetin

Questions?

Or to report an adverse event call 800-824-1706 Monday - Friday 9am - 4pm MST

PRINCIPAL DISPLAY PANEL

WinCo™ Foods

**Compare to the active ingredient in Advil®

Ibuprofen

Relieves: Minor Aches & Pains, Fever

IBUPROFEN TABLETS 200 MG (NSAID)/

PAIN RELIEVER - FEVER REDUCER

100 Coated Tablets

IBUPROFEN 
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-126
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
STARCH, CORN 
DEXTROSE MONOHYDRATE 
HYPROMELLOSES 
FERRIC OXIDE RED 
LACTOSE MONOHYDRATE 
LECITHIN, SOYBEAN 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE K30 
CARBOXYMETHYLCELLULOSE SODIUM 
SODIUM STARCH GLYCOLATE TYPE A CORN 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
ColorbrownScoreno score
ShapeROUNDSize10mm
FlavorImprint CodeIBU;200
Contains    
Packaging
#Item CodePackage Description
1NDC:67091-126-501 BOTTLE, PLASTIC in 1 CARTON
150 TABLET, COATED in 1 BOTTLE, PLASTIC
2NDC:67091-126-101 BOTTLE, PLASTIC in 1 CARTON
2100 TABLET, COATED in 1 BOTTLE, PLASTIC
3NDC:67091-126-05500 TABLET, COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07912912/15/2014
Labeler - WinCo Foods, LLC (056098817)

 
WinCo Foods, LLC

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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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