ACID REDUCER- famotidine tablet 
Publix Super Markets Inc

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Publix Super Markets, Inc. Acid Reducer 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

Principal Display Panel

FAMOTIDINE TABLETS, 10mg

acid reducer

ORIGINAL STRENGTH

Just one tablet prevents & relieves heartburn due to acid indigestion

ACTUAL SIZE

30 TABLETS

Compare to the Active Ingredient in Original Strength Pepcid® AC

Acid Reducer Carton Image #1

Acid Reducer Carton Image #1

Acid Reducer Carton Image #2

Acid Reducer Carton Image #2

ACID REDUCER 
famotidine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:56062-141
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE 10 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
Color PINK Score no score
Shape ROUND Size 8mm
Flavor Imprint Code L141
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:56062-141-65 3 in 1 CARTON
1 10 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075400 11/23/2009
Labeler - Publix Super Markets Inc (006922009)

Revised: 9/2013
Document Id: 02436e57-65fb-45a4-b712-c4a6e9317e73
Set id: a3ba9983-6747-45b2-b270-4ac1fb9d6e40
Version: 2
Effective Time: 20130916
 
Publix Super Markets Inc