IBUPROFEN- ibuprofen tablet 
Contract Pharmacal Corp.

----------

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:

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 chance is higher if you:

Heart attack and stroke warning: NSAIDs, except aspirin, increases 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

ASK 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 (1-800-222-1222) right away.

DIRECTIONS

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

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

XXXXX-10-18

Barcode

Peel here for more information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

See New Warnings

CONTRACT PHARMACAL CORP NDC 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

Ibuprofen white label 3909

See New Warnings


CONTRACT PHARMACAL CORP NDC 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

Ibuprofen Orange label 3846

See New Warnings


CONTRACT PHARMACAL CORP NDC 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 Brown label

IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10267-3852
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
STARCH, CORN (UNII: O8232NY3SJ)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
POVIDONE K30 (UNII: U725QWY32X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
Product Characteristics
ColorbrownScoreno score
ShapeROUND (convex) Size6mm
FlavorImprint Code C1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10267-3852-2250 in 1 BOTTLE; Type 0: Not a Combination Product01/15/2014
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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
STARCH, CORN (UNII: O8232NY3SJ)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
POVIDONE K30 (UNII: U725QWY32X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColororangeScoreno score
ShapeROUND (convex) Size6mm
FlavorImprint Code C1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10267-3846-2250 in 1 BOTTLE; Type 0: Not a Combination Product01/15/2014
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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
STARCH, CORN (UNII: O8232NY3SJ)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
POVIDONE K30 (UNII: U725QWY32X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUND (convex) Size6mm
FlavorImprint Code C1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10267-3909-2250 in 1 BOTTLE; Type 0: Not a Combination Product01/15/2014
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/FEIBusiness Operations
Contract Pharmacal Corp.057795122pack(10267-3852, 10267-3846, 10267-3909)
Establishment
NameAddressID/FEIBusiness Operations
Contract Pharmacal Corp.968334974manufacture(10267-3852, 10267-3846, 10267-3909)
Establishment
NameAddressID/FEIBusiness Operations
Contract Pharmacal Corp.968335112manufacture(10267-3852, 10267-3846, 10267-3909)

Revised: 11/2018
Document Id: 77cf0092-7436-14ba-e053-2991aa0ac112
Set id: 237bcb87-64a0-415b-bd53-e9d3b8bf33b6
Version: 13
Effective Time: 20181107
 
Contract Pharmacal Corp.