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ibuprofen by Contract Pharmacal Corp.

Dosage form: tablet
Ingredients: IBUPROFEN 200mg
Labeler: Contract Pharmacal Corp.
NDC Code: 10267-3852

3852, 3846, 3909

Important: Read all product information before using.
DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

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 ache
  • 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 non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for longer time than directed

DO NOT USE
  • if you have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer
  • right before or after heart surgery

ASK DOCTOR before use if
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • the 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 have asthma
  • you are taking a diuretic

ASK A DOCTOR OR PHARMACIST before use if you are
  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • under a doctor’s care for any serious condition
  • 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
  • you experience and 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 (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 of age 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 of age: ■ Ask a doctor

Other information

  • store between 20˚ to 25˚C (68˚to 77˚F)
  • avoid excessive heat above 40˚C (104˚F)

INACTIVE INGREDIENTS

(White) Carnauba Wax, Croscarmellose Sodium, Hypromellose, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, Povidone, Pregelatinized Starch, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid, and Titanium Dioxide.

(Orange) Croscarmellose Sodium, FD&C Yellow #6 Lake, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Pregelatinized Starch, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid, Talc and Titanium Dioxide.

(Brown) Croscarmellose Sodium, Hydroxypropylcellulose, Hypromellose, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Pregelatinized Starch, Red Iron Oxide, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid, and Titanium Dioxide.

QUESTIONS or COMMENTS?

Call 1-800-231-4670: weekdays 9:00 AM to 5:00 PM EST

**This product is not manufactured or distributed by McNeil, owner of the registered trademark Motrin®IB

Manufactured by:
Contract Pharmacal Corp.
135 Adams Avenue
Hauppauge, NY 11788 USA
www.cpc.com

Lot #/ Exp. Date

Peel here for more information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

New Information: Read Entire Label
CONTRACT PHARMACAL CORPNDC 10267-3909-2
**Compares to the active ingredient in Motrin ®IB
GLUTEN FREE

Ibuprofen Tablets, USP 200 mg
Pain Reliever/Fever Reducer
(NSAID)
250 Coated Tablets
DYE-FREE
NOT ACTUAL SIZE

New Information: Read Entire Label
CONTRACT PHARMACAL CORPNDC 10267-3846-2
**Compares to the active ingredient in Motrin ®IB
GLUTEN FREE

Ibuprofen Tablets, USP 200 mg
Pain Reliever/Fever Reducer
(NSAID)
250 Coated Tablets
NOT ACTUAL SIZE

New Information: Read Entire Label
CONTRACT PHARMACAL CORPNDC 10267-3852-2
**Compares to the active ingredient in Motrin ®IB
GLUTEN FREE

Ibuprofen Tablets, USP 200 mg
Pain Reliever/Fever Reducer
(NSAID)
250 Coated Tablets
NOT ACTUAL SIZE

IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10267-3852
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
STARCH, CORN 
CELLULOSE, MICROCRYSTALLINE 
STEARIC ACID 
SODIUM STARCH GLYCOLATE TYPE A CORN 
POVIDONE K30 
SILICON DIOXIDE 
FERRIC OXIDE RED 
TITANIUM DIOXIDE 
POLYETHYLENE GLYCOLS 
HYDROXYPROPYL CELLULOSE (TYPE H) 
HYPROMELLOSES 
Product Characteristics
ColorbrownScoreno score
ShapeROUND (convex) Size6mm
FlavorImprint CodeC1
Contains    
Packaging
#Item CodePackage Description
1NDC:10267-3852-2250 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07126501/15/2014
IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10267-3846
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
STARCH, CORN 
CELLULOSE, MICROCRYSTALLINE 
STEARIC ACID 
SODIUM STARCH GLYCOLATE TYPE A CORN 
POVIDONE K30 
SILICON DIOXIDE 
POLYVINYL ALCOHOL 
POLYETHYLENE GLYCOLS 
FD&C YELLOW NO. 6 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColororangeScoreno score
ShapeROUND (convex) Size6mm
FlavorImprint CodeC1
Contains    
Packaging
#Item CodePackage Description
1NDC:10267-3846-2250 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07126501/15/2014
IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10267-3909
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
STARCH, CORN 
CELLULOSE, MICROCRYSTALLINE 
STEARIC ACID 
SODIUM STARCH GLYCOLATE TYPE A CORN 
POVIDONE K30 
SILICON DIOXIDE 
TITANIUM DIOXIDE 
HYDROXYPROPYL CELLULOSE (TYPE H) 
POLYETHYLENE GLYCOLS 
POLYSORBATE 80 
CARNAUBA WAX 
Product Characteristics
ColorwhiteScoreno score
ShapeROUND (convex) Size6mm
FlavorImprint CodeC1
Contains    
Packaging
#Item CodePackage Description
1NDC:10267-3909-2250 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07126501/15/2014
Labeler - Contract Pharmacal Corp. (057795122)
Registrant - Contract Pharmacal Corp. (057795122)
Establishment
NameAddressID/FEIOperations
Contract Pharmacal Corp.057795122pack(10267-3852, 10267-3846, 10267-3909)
Establishment
NameAddressID/FEIOperations
Contract Pharmacal Corp.968334974manufacture(10267-3852, 10267-3846, 10267-3909)
Establishment
NameAddressID/FEIOperations
Contract Pharmacal Corp.968335112manufacture(10267-3852, 10267-3846, 10267-3909)

Revised: 12/2017
 
Contract Pharmacal Corp.

← 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.

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