IBUPROFEN - ibuprofen tablet 
Apotheca, Inc

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Ibuprofen Tablets, USP 200mg (NSAID)

ACTIVE INGREDIENT

Ibuprofen 200 mg (NSAID)*

* nonstreoidal anti-inflammatory drug

PURPOSE

Pain reliever / fever reducer


Use(s)

temporarily relieves minor aches and pain due to :
backache
headache
menstrual cramps
minor pain of arthritis
muscular aches
the common cold
toothache
temporarily reduces fever

WARNINGS

Allergy alerts: Ibuprofen may cause a severe allergy 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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you:

DO NOT USE

ASK DOCTOR/PHARMACIST

Ask a doctor before use if you have


Ask a doctor or pharmacist before use if you are


When using this product


Stop use and ask doctor if

These are signs of stomach bleeding.

PREGNACNCY 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 a 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 PoisonControlCenter right away. (1-800-222-1222)

INACTIVE INGREDIENTS

colloidal silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinised starch, talc, titanium dioxide.

QUESTIONS

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

store between 20-25 0c (68-77 0 F).

PRINCIPAL DISPLAY PANEL

Manufactured for:
Marksans Pharma Inc.
Lake Grove, NY11755, USA

Manufactured by:
Marksans Pharma Ltd.
Verna, Goa-403722, India

Repackaged and Distributed by:
Apotheca, Inc.
Phoenix, AZ 85006

Repackaged and Distributed for:

RejuviLife

Phoenix, AZ 85015

NDC 12634-518-74

IBUPROFEN

MAXIMUM STRENGTH

WITHOUT A PRESCRIPTION 

BROWN COATED TABLETS

Pain Reliver

Fever Reducer

RejuviLife®

24 TABLETS 200MG

LABEL

IBUPROFEN  
ibuprofen tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:12634-518(NDC:25000-114)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorbrownScoreno score
ShapeROUNDSize10mm
FlavorImprint Code 114
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12634-518-7424 in 1 BOTTLE
2NDC:12634-518-01100 in 1 BOTTLE
3NDC:12634-518-101000 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09123902/14/2014
Labeler - Apotheca, Inc (051457844)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca, Inc051457844repack(12634-518)

Revised: 3/2014
Document Id: 2757f53a-602c-4678-80f5-61c3d9dfd4a3
Set id: 3fd625e4-0d06-4efb-abd1-42281e7a6af0
Version: 1
Effective Time: 20140303
 
Apotheca, Inc