HEARTBURN RELEIF ORIGINAL STRENGTH- famotidine tablet 
Major Pharmaceuticals

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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 oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, talc, titanium dioxide, triacetin

Questions or comments?

1-800-719-9260

Principal Display Panel

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

60 Tablets

TABLETS

Heartburn Relief Image 1
Heartburn Relief Image 2
HEARTBURN RELEIF  ORIGINAL STRENGTH
famotidine tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0904-5529
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE10 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
TALC 
TITANIUM DIOXIDE 
TRIACETIN 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize8mm
FlavorImprint Code L141
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-5529-8730 in 1 CARTON
11 in 1 BLISTER PACK
2NDC:0904-5529-521 in 1 CARTON
260 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07540009/09/2009
Labeler - Major Pharmaceuticals (191427277)

Revised: 1/2014
Document Id: 840fd61a-8e6c-41e4-ad2d-0754ed8abbc2
Set id: be275c48-18bf-45f6-891d-36d89327813e
Version: 2
Effective Time: 20140116
 
Major Pharmaceuticals