RANITIDINE- ranitidine tablet, coated 
Wockhardt USA LLC.

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Ranitidine Tablet USP, 150 mg

OTC - ACTIVE INGREDIENT SECTION

Ranitidine 150 mg (as ranitidine hydrochloride 168 mg)

OTC - PURPOSE SECTION

Acid reducer

USE

WARNINGS

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

DO NOT USE

●  if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.    

●  with other acid reducers

●  if you have kidney disease, except under the advice and supervision of a doctor

ASK A DOCTOR BEFORE USE IF YOU HAVE

o frequent chest pain

o frequent wheezing, particularly with heartburn

o unexplained weight loss

o nausea or vomiting

o stomach pain

o had heartburn over 3 months. This may be a sign of a more serious condition.

o heartburn with lightheadedness, sweating or dizziness

o chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness

Stop use and ask a doctor if

o your heartburn continues or worsens

o you need to take this product for more than 14 days

PREGNANCY OR BREAST FEEDING

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

OTC - KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS

● adults and children 12 years and over:

   ▪ to relieve symptoms, swallow 1 tablet with a glass of water

   ▪ to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn

   ▪ can be used up to twice daily (do not take more than 2 tablets in 24 hours)

●  children under 12 years: ask a doctor

OTHER INFORMATION

INACTIVE INGREDIENT

colloidal silicon dioxide, croscarmellose sodium, diethyl phthalate, FD&C Yellow No. 6, 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ranitidine Tablets USP, 150 mg (OTC)

150 mg - Acid reducer

64679-741-06

Label 150 mg
RANITIDINE 
ranitidine tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64679-741
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)  
DIETHYL PHTHALATE (UNII: UF064M00AF)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
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:64679-741-011 in 1 CARTON11/26/2007
110 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:64679-741-021 in 1 CARTON11/26/2007
2100 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:64679-741-051 in 1 CARTON11/26/2007
3500 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:64679-741-0310 in 1 CARTON11/26/2007
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:64679-741-066000 in 1 POUCH; Type 0: Not a Combination Product11/26/2007
6NDC:64679-741-0030000 in 1 DRUM; Type 0: Not a Combination Product11/26/2007
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07865311/26/2007
Labeler - Wockhardt USA LLC. (170508365)
Registrant - Wockhardt Limited (650069115)
Establishment
NameAddressID/FEIBusiness Operations
Wockhardt Limited676257570ANALYSIS(64679-741) , LABEL(64679-741) , MANUFACTURE(64679-741) , PACK(64679-741)

Revised: 12/2018
Document Id: b389e8a7-8065-48f9-a0bc-fb30bed04c2d
Set id: f7aa08fc-5d10-4067-8f20-3c3e176e3e35
Version: 2
Effective Time: 20181207
 
Wockhardt USA LLC.