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Ibuprofen IB by Chain Drug Marketing Association

Medically reviewed on October 30, 2017

Dosage form: tablet, coated
Ingredients: IBUPROFEN 200mg
Labeler: Chain Drug Marketing Association
NDC Code: 63868-794

1111 - QCH - 2014-1028

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
    • muscular aches
    • minor pain of arthritis
    • toothache
    • backache
    • the common cold
    • menstrual cramps
  • 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 20º-25ºC (68º-77ºF)
  • 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, hypromellose, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone K30, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide, triacetin

PRINCIPAL DISPLAY PANEL

NDC 63868-794-01

QUALITY CHOICE

†Compare to Active Ingredient in MOTRIN® IB

Ibuprofen IB

Non-Prescription Strength

Ibuprofen Tablets USP, 200mg

Pain Reliever / Fever Reducer (NSAID)

100 Coated Tablets

IBUPROFEN IB 
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-794
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
STARCH, CORN 
HYPROMELLOSES 
FD&C YELLOW NO. 6 
ALUMINUM OXIDE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
POVIDONE K30 
SODIUM STARCH GLYCOLATE TYPE A CORN 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize10mm
FlavorImprint CodeIBU;200
Contains    
Packaging
#Item CodePackage Description
1NDC:63868-794-011 BOTTLE, PLASTIC in 1 CARTON
1100 TABLET, COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09135505/14/2014
Labeler - Chain Drug Marketing Association (011920774)

 
Chain Drug Marketing Association

← See all Ibuprofen IB brands

Further information

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

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