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Ibuprofen by Major Pharmaceuticals

Dosage form: tablet, film coated
Ingredients: IBUPROFEN 200mg
Labeler: Major Pharmaceuticals
NDC Code: 0904-7915

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.

Major 44-291-Delisted

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:
    • toothache
    • the common cold
    • menstrual cramps
    • backache
    • headache
    • 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:

  • facial swelling
  • hives
  • asthma (wheezing)
  • rash
  • shock
  • skin reddening
  • blister

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:

  • take more or for a longer time than directed
  • are age 60 or older
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • take a blood thinning (anticoagulant) or steroid drug
  • have had stomach ulcers or bleeding problems
  • have 3 or more alcoholic drinks every day while using this product

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
  • 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, kidney disease, asthma, or had a stroke

  • 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:

    • have bloody or black stools

    • vomit blood
    • feel faint

    • have stomach pain that does not get better

  • you have symptoms of heart problems or stroke

    • chest pain
    • slurred speech
    • leg swelling
    • trouble breathing
    • 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
  • use by expiration date on package

  • store between 20°-25°C (68°-77°F)

  • avoid excessive heat 40°C (104°F)

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?

(800) 616-2471

Principal Display Panel

MAJOR®

NDC 0904-7915-80

Compare to the active ingredient in Advil® Tablets†

Ibuprofen
Tablets
Ibuprofen Tablets, USP 200 mg

Pain Reliever
Fever Reducer (NSAID)

1000 COATED TABLETS

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

50844        REV1116E29116

Distributed by
MAJOR PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152 USA      M-17        Rev.09/17

Re-order No. 700643

Major 44-291

IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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:0904-7915-801 BOTTLE, PLASTIC in 1 CARTON
11000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34305/24/1988
Labeler - Major Pharmaceuticals (191427277)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(0904-7915)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(0904-7915)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(0904-7915)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(0904-7915)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(0904-7915)

Revised: 10/2017
 
Major Pharmaceuticals

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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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