RANITIDINE - ranitidine tablet, coated 
WOCKHARDT LIMITED

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Active ingredient (in each tablet)

Ranitidine 75 mg (as ranitidine hydrochloride 84 mg)

Purpose

Acid reducer

Uses

Warnings

Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, diethyl phthalate, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose and titanium dioxide.

Questions or Comments?
Call 1-800-346-6854

Read the directions, consumer information leaflet and warnings before use. Keep the carton. It contains important information.

Manufactured by:
Wockhardt Limited,
Mumbai, India.

Distributed by:
Wockhardt USA LLC.
20 Waterview Blvd.
Parsippany, NJ 07054
USA.

Iss.020410

500 T Label

500 T Carton

RANITIDINE 
ranitidine tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55648-740
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE75 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
DIETHYL PHTHALATE (UNII: UF064M00AF)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
Product Characteristics
Colorpink (Pink colored film coated) Scoreno score
ShapeHEXAGON (6 sided)Size8mm
FlavorImprint Code W;75
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55648-740-011 in 1 CARTON
110 in 1 BOTTLE
2NDC:55648-740-021 in 1 CARTON
2100 in 1 BOTTLE
3NDC:55648-740-041 in 1 CARTON
3500 in 1 BOTTLE
4NDC:55648-740-0310 in 1 CARTON
410 in 1 BLISTER PACK
5NDC:55648-740-0510000 in 1 POUCH
6NDC:55648-740-0060000 in 1 DRUM
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07888407/31/2008
Labeler - WOCKHARDT LIMITED (650069115)
Establishment
NameAddressID/FEIBusiness Operations
WOCKHARDT LIMITED676257570manufacture

Revised: 11/2011
Document Id: f60514be-7bf5-48bb-9a26-e1a70b7e74c1
Set id: ff374897-6078-4061-be9c-0b880595ab1f
Version: 1
Effective Time: 20111121
 
WOCKHARDT LIMITED