IBUPROFEN - ibuprofen tablet 
Apotheca Inc.

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Ibuprofen Tablets, USP (NSAID)Pain Reliever/ Fever Reducer 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.

Alcohol Warning: If you consume 3 or more alcohol drinks per day, ask your Doctor whether you should take Ibuprofen or other pain relievers/fever reducers.

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you:

DO NOT USE

ASK DOCTOR

Ask a doctor before use if you have

Ask a doctor 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 1-800-362-0101 (Arizona only) immediately.

DIRECTIONS



Adults and children 12 years and older
  • take 1 caplet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 caplet, 2 caplets may be used
  • do not exceed 6 caplets in a 24-hour period, unless directed by a physician
  • take with food or milk, if occasional and mild heartburn, upset stomach, or stomach pain occurs with use
  • consult a physician if these symptoms are more thsn mild or if they persist
Children under 12 years
  • not for use

OTHER INFORMATION

Other information Inactive ingredients

Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Hypromellose, Iron Oxide Red, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Corn Starch, Titanium Dioxide.


QUESTIONS OR COMMENTS

Call 1-800-262-5244

Monday though Friday 9AM – 2PM MST

Distributed by:

RejuviLife, Phoenix, AZ

RejuviLife is a trademark of Apotheca Inc.

PACKAGE LABEL,PRINCIPAL DISPLAY PANEL,ADDITIONAL LABELS UPON REQUEST

NDC 12634-860-01

IBUPROFEN

MAXIMUM STRENGTH
WITHOUT A PRESCRIPTION

Pain Reliever
Fever Reducer

RejuviLife®

100 CAPLETS

200 MG

image of label

IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12634-860(NDC:53746-142)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSE (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorbrown (BROWN) Scoreno score
ShapeOVAL (CAPSULE-SHAPE) Size13mm
FlavorImprint Code IP;142
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12634-860-2424 in 1 BOTTLE, PLASTIC
2NDC:12634-860-01100 in 1 BOTTLE, PLASTIC
3NDC:12634-860-101000 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07133309/16/2009
Labeler - Apotheca Inc. (051457844)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Inc.051457844relabel, repack

Revised: 2/2010
Document Id: 6e315790-ef94-4772-8e76-2565f8b097d4
Set id: a6e57acd-b02a-472e-9cc6-8d4aea246164
Version: 3
Effective Time: 20100219
 
Apotheca Inc.