RANITIDINE tablet, coated

RANITIDINE by

Drug Labeling and Warnings

RANITIDINE by is a Otc medication manufactured, distributed, or labeled by WOCKHARDT LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Ranitidine 75 mg (as ranitidine hydrochloride 84 mg)

Purpose

Acid reducer

Uses

• 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

• frequent wheezing, particularly with heartburn       
• frequent chest pain       
• stomach pain
• unexplained weight loss                                         
• nausea or vomiting          
• had heartburn over 3 months. This may be a sign of a more serious condition.
• heartburn with lightheadedness, sweating or dizziness.
• 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

• your heartburn continues or worsens
• 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.

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 ingredients

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

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RANITIDINE 
ranitidine tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55648-740
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7)	RANITIDINE	75 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	pink (Pink colored film coated)	Score	no score
Shape	HEXAGON (6 sided)	Size	8mm
Flavor		Imprint Code	W;75
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55648-740-01	1 in 1 CARTON
1		10 in 1 BOTTLE
2	NDC: 55648-740-02	1 in 1 CARTON
2		100 in 1 BOTTLE
3	NDC: 55648-740-04	1 in 1 CARTON
3		500 in 1 BOTTLE
4	NDC: 55648-740-03	10 in 1 CARTON
4		10 in 1 BLISTER PACK
5	NDC: 55648-740-05	10000 in 1 POUCH
6	NDC: 55648-740-00	60000 in 1 DRUM

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078884	07/31/2008

Labeler - WOCKHARDT LIMITED (650069115)

Establishment
Name	Address	ID/FEI	Business Operations
WOCKHARDT LIMITED		676257570	manufacture