Major Pharmaceuticals Heartburn Relief Drug Facts

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

Easy Push-Thru Package

Original Strength

Heartburn Relief

Famotidine Tablets, 10 mg

Acid Reducer

Just One Tablet Prevents & Relieves Heartburn Due to Acid Indigestion

Compare to the active ingredient of Original Strength Pepcid® AC

Actual Size

Tablets

Heartburn Relief Carton

HEARTBURN RELEIF ORIGINAL STRENGTH
famotidine tablet

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:0904-5529
Route of Administration	ORAL	DEA Schedule

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

Ingredient Name	Strength
Inactive Ingredients
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE

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

#	Item Code	Package Description
Packaging
1	NDC:0904-5529-87	3 in 1 CARTON
1		10 in 1 BLISTER PACK
2	NDC:0904-5529-52	1 in 1 CARTON
2		60 in 1 BOTTLE

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

Labeler - Major Pharmaceuticals (191427277)

Revised: 9/2009

Document Id: be275c48-18bf-45f6-891d-36d89327813e

Set id: be275c48-18bf-45f6-891d-36d89327813e

Version: 1

Effective Time: 20090909

Major Pharmaceuticals