Active ingredient (in each tablet)

Famotidine USP 10 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.
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 15 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
TAMPER-EVIDENT: Do not use this product if carton has been opened, if blister backing appears to have been disturbed, or if individual blister units are broken or torn.
keep the carton. It contains important information.
store at 20° to 25°C (68° to 77°F)
protect from moisture

Inactive ingredients

colloidal silicon dioxide, FD & C Red #40 aluminum lake, FD & C Yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide

Questions?

call 1-888-838-2872, weekdays, 8 AM to 5 PM Eastern Time

PRINCIPAL DISPLAY PANEL - 30 Tablets Carton

Prevents and Relieves Heartburn Due to Acid

NDC 0172-2662-46

Tamper-Evident

FAMOTIDINE
Tablets USP

10 mg

ACID REDUCER

30 TABLETS Just One Per Dose

TEVA

PRINCIPAL DISPLAY PANEL - 30 Tablets Carton

FAMOTIDINE
famotidine tablet

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	0172-2662
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Famotidine (Famotidine)	Famotidine	10 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE
FD&C RED NO. 40
FD&C YELLOW NO. 6
HYPROMELLOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE

Product Characteristics
Color	ORANGE (PEACH)	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	10;2662
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0172-2662-46	30 BLISTER In 1 CARTON	contains a BLISTER PACK (0172-2662-00)
1	0172-2662-00	1 TABLET In 1 BLISTER PACK	This package is contained within the CARTON (0172-2662-46)
2	0172-2662-48	50 BLISTER In 1 CARTON	contains a BLISTER PACK (0172-2662-00)
2	0172-2662-00	1 TABLET In 1 BLISTER PACK	This package is contained within the CARTON (0172-2662-48)
3	0172-2662-72	70 BLISTER In 1 CARTON	contains a BLISTER PACK (0172-2662-00)
3	0172-2662-00	1 TABLET In 1 BLISTER PACK	This package is contained within the CARTON (0172-2662-72)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075512	02/24/2010

Labeler - IVAX Pharmaceuticals, Inc. (884075235)

Establishment
Name	Address	ID/FEI	Operations
IVAX Pharmaceuticals Ireland		985123517	MANUFACTURE

Revised: 02/2010IVAX Pharmaceuticals, Inc.