HEARTBURN RELIEF- famotidine tablet

Heartburn Relief by

Drug Labeling and Warnings

Heartburn Relief by is a Otc medication manufactured, distributed, or labeled by Select Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Famotidine USP 10mg

PURPOSE

Acid Reducer

DOSAGE & ADMINISTRATION

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

INDICATIONS & USAGE

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

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

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.

INACTIVE INGREDIENT

Inactive ingredients hydroxypropyl

cellulose, hypromellose, iron oxide red, magnesium

stearate, microcrystalline cellulose, polyethylene

glycol 400, pregelatinized starch, talc, titanium

dioxide

PRINCIPAL DISPLAY PANEL

MM1

INGREDIENTS AND APPEARANCE

HEARTBURN RELIEF  
famotidine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52904-448
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8)	FAMOTIDINE	10 mg

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
STARCH, CORN (UNII: O8232NY3SJ)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	pink (ROSE PINK)	Score	no score
Shape	ROUND (W972)	Size	8mm
Flavor		Imprint Code	W972
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52904-448-01	1 in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077146	03/14/2014

Labeler - Select Corporation (053805599)

Registrant - Select Corporation (053805599)