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Ibuprofen by GREENBRIER INTERNATIONAL, INC.

Medically reviewed on September 5, 2017

Dosage form: tablet, film coated
Ingredients: IBUPROFEN 200mg
Labeler: GREENBRIER INTERNATIONAL, INC.
NDC Code: 33992-0291

Assured 44-291

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
  • shock
  • facial swelling
  • rash
  • blisters
  • skin reddening
  • asthma (wheezing)

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 

Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer 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 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 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

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
  • you have symptoms of heart problems or stroke
  • chest pain
  • trouble breathing
  • leg swelling
  • slurred speech
  • weakness in one part or side of body
  • 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 20º-25ºC (68º-77ºF)
  • avoid excessive heat 40ºC (104ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

carnauba wax, colloidal silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal Display Panel

ASSURED™

COMPARE TO ACTIVE INGREDIENT OF
ADVIL® TABLETS

Ibuprofen

• Ibuprofen Tablets USP, 200 mg
Pain reliever / Fever reducer (NSAID)

Actual Size

100 tablets

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

This product is not manufactured or distributed by Pfizer
Consumer Healthcare, owner of the registered trademark Advil®
Tablets.    50844           REV1116B29112

DISTRIBUTED BY
GREENBRIER INTERNATIONAL, INC.
500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

 

Assured 44-291

IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0291
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE, UNSPECIFIED 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
POLYDEXTROSE 
STEARIC ACID 
TITANIUM DIOXIDE 
STARCH, CORN 
ANHYDROUS LACTOSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
FERRIC OXIDE RED 
Product Characteristics
ColorBROWNScoreno score
ShapeROUNDSize10mm
FlavorImprint Code44;291
Contains    
Packaging
#Item CodePackage Description
1NDC:33992-0291-21 BOTTLE, PLASTIC in 1 CARTON
1100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
2NDC:33992-0291-01 BOTTLE, PLASTIC in 1 CARTON
240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
3NDC:33992-0291-51 BOTTLE, PLASTIC in 1 CARTON
350 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07501005/24/1988
Labeler - GREENBRIER INTERNATIONAL, INC. (610322518)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(33992-0291)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(33992-0291)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(33992-0291)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(33992-0291)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(33992-0291)

 
GREENBRIER INTERNATIONAL, INC.

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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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