Active ingredient (in each tablet)

Famotidine 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 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
keep the carton. It contains important information.
store at 20°-25°C (68°-77°F)
protect from moisture and light

Inactive ingredients

carnauba wax, hypromellose, iron oxides, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polydextrose, polyethylene glycol, talc, titanium dioxide, triacetin

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Original Strength Pepcid® AC active ingredient

Heartburn Prevention

Famotidine Tablets, 10 mg

Acid Reducer

Just One Tablet Relieves and Prevents Heartburn Due to Acid Indigestion

Original Strength

Actual Size

Heartburn Prevention Carton Image 1

Heartburn Prevention Carton Image 2

HEARTBURN PREVENTION ACID REDUCER
famotidine tablet

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	37808-141
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
CARNAUBA WAX
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
POLYDEXTROSE
POLYETHYLENE GLYCOL
TALC
TITANIUM DIOXIDE
TRIACETIN
FERRIC OXIDE RED
FERRIC OXIDE YELLOW

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	L141
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	37808-141-72	1 BOTTLE In 1 CARTON	contains a BOTTLE
1		60 TABLET In 1 BOTTLE	This package is contained within the CARTON (37808-141-72)
2	37808-141-65	3 BLISTER PACK In 1 CARTON	contains a BLISTER PACK
2		10 TABLET In 1 BLISTER PACK	This package is contained within the CARTON (37808-141-65)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075400	09/11/2009

Labeler - H E B (007924756)

Revised: 02/2011H E B