RANITIDINE- ranitidine tablet, coated 
Wockhardt USA LLC.

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Ranitidine Tablet USP, 75 mg

OTC - ACTIVE INGREDIENT SECTION

Ranitidine 75 mg (as ranitidine hydrochloride 84 mg)

OTC - PURPOSE SECTION

Acid reducer

USAGE

● relieves heartburn associated with acid indigestion and sour stomach

● prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages

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

ASK A DOCTOR BEFORE USE IF YOU HAVE

o frequent wheezing, particularly with heartburn

o frequent chest pain

o stomach pain

o unexplained weight loss

o nausea or vomiting 

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

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

●   Blister:  Do not use if individual unit is open or torn

●   Bottle: do not use if printed foil under bottle cap is open or torn

●   store at 20°-25°C (68°-77°F)

●   avoid excessive heat or humidity

●   this product is sugar free

INACTIVE INGREDIENT

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ranitidine Tablets USP, 75 mg (OTC)

75 mg - Acid reducer

64679-740-05

Label 75 mg
RANITIDINE 
ranitidine tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64679-740
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)  
DIETHYL PHTHALATE (UNII: UF064M00AF)  
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
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:64679-740-011 in 1 CARTON07/31/2008
110 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:64679-740-021 in 1 CARTON07/31/2008
2100 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:64679-740-041 in 1 CARTON07/31/2008
3500 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:64679-740-0310 in 1 CARTON07/31/2008
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:64679-740-0510000 in 1 POUCH; Type 0: Not a Combination Product07/31/2008
6NDC:64679-740-0060000 in 1 DRUM; Type 0: Not a Combination Product07/31/2008
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07888407/31/2008
Labeler - Wockhardt USA LLC. (170508365)
Registrant - Wockhardt Limited (650069115)
Establishment
NameAddressID/FEIBusiness Operations
Wockhardt Limited676257570ANALYSIS(64679-740) , LABEL(64679-740) , MANUFACTURE(64679-740) , PACK(64679-740)

Revised: 12/2018
Document Id: f14b4db0-bafe-4847-8600-d88ff3da1acc
Set id: e32f654d-76c6-48d3-96fd-c00e1892ca63
Version: 2
Effective Time: 20181206
 
Wockhardt USA LLC.