BERKLEY AND JENSEN IBUPROFEN - ibuprofen tablet 
BJWC

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BJWC Ibuprofen Drug Facts

Active ingredient (in each tablet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

Warnings

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

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 chances are higher if you

Do not use

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

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. (1-800-222-1222)

Directions

adults and children 12 years and older

 

  • 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

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, iron oxides, microcrystalline cellulose, polyethylene glycol, polysorbate 80, stearic acid, titanium dioxide

Questions or comments?

1-800-934-1204

Principal Display Panel

Compare to the Active Ingredient of Advil®

Ibuprofen

Tablets USP, 200 mg

Pain Reliever/Fever Reducer (NSAID)

See New Warnings Information

Gluten Free

Ibuprofen Label

Ibuprofen Label


BERKLEY AND JENSEN IBUPROFEN 
ibuprofen   tablet
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 68391-604
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
COLLOIDAL SILICON DIOXIDE  
STARCH, CORN  
CROSCARMELLOSE SODIUM  
HYPROMELLOSES  
CELLULOSE, MICROCRYSTALLINE  
STEARIC ACID  
TITANIUM DIOXIDE  
POLYSORBATE 80  
POLYETHYLENE GLYCOL  
Product Characteristics
Color BROWN Score no score
Shape ROUND Size 10mm
Flavor Imprint Code I2
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 68391-604-62 1 BOTTLE In 1 CARTON contains a BOTTLE
1 24 TABLET In 1 BOTTLE This package is contained within the CARTON (68391-604-62)
2 68391-604-90 500 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072096 06/20/2007

Labeler - BJWC (159082692)
Revised: 05/2009 BJWC