FAMOTIDINE by WOCKHARDT LIMITED FAMOTIDINE tablet

FAMOTIDINE by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drugs Facts

Active ingredient (in each tablets)

Famotidine USP 20 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 food and beverages

Warnings

Allergy alert: Do not use if you are allergic to famotidine 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.
• if you have kidney disease, except under the advice and supervision of a doctor
• with other acid reducers

Ask a doctor before use if you have

• 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
• frequent chest pain
• frequent wheezing, particularly with heartburn
• unexplained weight loss
• nausea or vomiting
• stomach pain

Stop use and ask a doctor if

• your heartburn continues or worsens
• you need to take this product for more than 14 days

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

• adults and children 12 years and over:
• to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
• to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn
• do not use more than 2 tablets in 24 hours
• children under 12 years: ask a doctor

Other information

• read the directions and warnings before use
• store at 20°-25°C (68°-77°F)
• keep the carton. It contains important information.
• protect from moisture

Inactive ingredients

Hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, magnesium stearate, polyethylene glycol, pregelatinized starch, talc and titanium dioxide.

Questions or comments?

Call 1-800-346-6854

Manufactured by:
Wockhardt Limited,
Mumbai, India.

Distributed by:
Wockhardt USA LLC.
20 Waterview Blvd.
Parsippany, NJ 07054
USA.

Iss.130810

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FAMOTIDINE 
famotidine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55648-374
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8)	FAMOTIDINE	20 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)
TALC (UNII: 7SEV7J4R1U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)

Product Characteristics
Color	white (white)	Score	no score
Shape	ROUND (barrel shaped)	Size	9mm
Flavor		Imprint Code	W374
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55648-374-01	1 in 1 CARTON
1		30 in 1 BOTTLE
2	NDC: 55648-374-08	1 in 1 CARTON
2		30 in 1 BOTTLE
3	NDC: 55648-374-05	1 in 1 CARTON
3		500 in 1 BOTTLE
4	NDC: 55648-374-07	10 in 1 CARTON
4		10 in 1 BLISTER PACK
5	NDC: 55648-374-00	38000 in 1 DRUM
6	NDC: 55648-374-09	6500 in 1 DRUM

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090837	08/06/2010

Labeler - WOCKHARDT LIMITED (650069115)