RANITIDINE - ranitidine tablet, coated 
WOCKHARDT LIMITED

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Drug Facts

Active ingredient (in each tablet)

Ranitidine 150 mg (as ranitidine hydrochloride 168 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, FD and C yellow # 6 aluminum lake, 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.

Rev.151111

500 T Label

500 T Carton

RANITIDINE 
ranitidine tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55648-741
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE150 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
DIETHYL PHTHALATE (UNII: UF064M00AF)  
Product Characteristics
Colororange (orange colored film coated) Scoreno score
ShapeHEXAGON (6 sided)Size10mm
FlavorImprint Code W741
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55648-741-011 in 1 CARTON
110 in 1 BOTTLE
2NDC:55648-741-021 in 1 CARTON
2100 in 1 BOTTLE
3NDC:55648-741-051 in 1 CARTON
3500 in 1 BOTTLE
4NDC:55648-741-0310 in 1 CARTON
410 in 1 BLISTER PACK
5NDC:55648-741-066000 in 1 POUCH
6NDC:55648-741-0030000 in 1 DRUM
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07865311/26/2007
Labeler - WOCKHARDT LIMITED (650069115)
Establishment
NameAddressID/FEIBusiness Operations
WOCKHARDT LIMITED676257570manufacture

Revised: 11/2011
Document Id: e0f509b6-6e58-4f2d-8abf-84d4852cf9a2
Set id: d6cfdf6c-9b09-440e-81a4-04d45d247751
Version: 1
Effective Time: 20111115
 
WOCKHARDT LIMITED