Skip to Content

← See all Ibuprofen brands

Ibuprofen by Avera McKennan Hospital

Medically reviewed on March 30, 2017

Dosage form: tablet, film coated
Ingredients: IBUPROFEN 200mg
Labeler: Avera McKennan Hospital
NDC Code: 69189-7915

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Rite Aid 44-329

Active ingredient (in each brown 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

  • 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
  • stomach bleeding warning applies to you

  • you have a history of stomach problems, such as heartburn

  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

  • you are taking a diuretic

  • you have asthma

  • you have problems or serious side effects from taking pain relievers or fever reducers

Ask a doctor or pharmacist before use if you are
  • taking any other drug
  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • under a doctor"s care for any serious condition

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 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 20°-25°C (68°-77°F)

  • avoid excessive heat 40°C (104°F)

  • use by expiration date on package

Inactive ingredients

carnauba wax, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

(800) 616-2471

Principal Display Panel

NDC 69189-7915-1 single dose pack with 1 tablet as repackaged by Avera McKennan Hospital

IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69189-7915(NDC:0904-7915)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
Product Characteristics
ColorBROWNScoreno score
ShapeROUNDSize10mm
FlavorImprint Code44;291
Contains    
Packaging
#Item CodePackage Description
1NDC:69189-7915-11 TABLET, FILM COATED in 1 DOSE PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34310/19/2016
Labeler - Avera McKennan Hospital (068647668)
Establishment
NameAddressID/FEIOperations
Avera McKennan Hospital068647668relabel(69189-7915), repack(69189-7915)

 
Avera McKennan Hospital

← See all Ibuprofen brands

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.

Hide