RANITIDINE tablet, coated

RANITIDINE by

Drug Labeling and Warnings

RANITIDINE by is a Otc medication manufactured, distributed, or labeled by Wockhardt USA LLC., Wockhardt Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OTC - ACTIVE INGREDIENT SECTION

Ranitidine 150 mg (as ranitidine hydrochloride 168 mg)

OTC - PURPOSE SECTION

Acid reducer

USE

• 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

●  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

• 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, 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

INGREDIENTS AND APPEARANCE

RANITIDINE 
ranitidine tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64679-741
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7)	RANITIDINE	150 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	ORANGE (orange colored film coated)	Score	no score
Shape	HEXAGON (6 SIDED)	Size	10mm
Flavor		Imprint Code	W741
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64679-741-01	1 in 1 CARTON	11/26/2007
1		10 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 64679-741-02	1 in 1 CARTON	11/26/2007
2		100 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 64679-741-05	1 in 1 CARTON	11/26/2007
3		500 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 64679-741-03	10 in 1 CARTON	11/26/2007
4		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC: 64679-741-06	6000 in 1 POUCH; Type 0: Not a Combination Product	11/26/2007
6	NDC: 64679-741-00	30000 in 1 DRUM; Type 0: Not a Combination Product	11/26/2007

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078653	11/26/2007

Labeler - Wockhardt USA LLC. (170508365)

Registrant - Wockhardt Limited (650069115)

Establishment
Name	Address	ID/FEI	Business Operations
Wockhardt Limited		676257570	ANALYSIS(64679-741) , LABEL(64679-741) , MANUFACTURE(64679-741) , PACK(64679-741)