FAMOTIDINE- famotidine tablet 
IVAX Pharmaceuticals, Inc.

----------

FAMOTIDINE
Tablets USP
10 mg
ACID REDUCER

Drug Facts

Active ingredient (in each tablet)

Famotidine USP, 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 at any time from 15 to 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
TAMPER-EVIDENT: Do not use this product if carton has
been opened, if blister backing appears to have been
disturbed, or if individual blister units are broken or torn.
keep the carton. It contains important information.
store at 20° to 25°C (68° to 77°F)
protect from moisture

Inactive ingredients

colloidal silicon dioxide, FD&C Red #40 aluminum lake,
FD&C Yellow #6 aluminum lake, hypromellose, magnesium
stearate, microcrystalline cellulose, polyethylene glycol,
pregelatinized starch, sodium starch glycolate, talc,
titanium dioxide

Questions?

call 1-888-838-2872, weekdays, 8 AM to 5 PM Eastern Time

Package/Label Display Panel

Famotidine Tablets 10 mg 30's Carton

Famotidine Tablets 10 mg 30's Carton Text

Prevents and Relieves Heartburn Due to Acid

NDC 0172-2662-46

Tamper-Evident

FAMOTIDINE
Tablets USP

10 mg

ACID REDUCER

30 TABLETS Just One Per Dose

TEVA

FAMOTIDINE 
famotidine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0172-2662
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE10 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorORANGE (PEACH) Scoreno score
ShapeROUNDSize9mm
FlavorImprint Code 10;2662
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0172-2662-4630 in 1 CARTON05/23/201010/31/2015
1NDC:0172-2662-001 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0172-2662-4850 in 1 CARTON02/18/201010/31/2015
2NDC:0172-2662-001 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:0172-2662-7270 in 1 CARTON02/18/201001/31/2016
3NDC:0172-2662-001 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07551202/18/201001/31/2016
Labeler - IVAX Pharmaceuticals, Inc. (884075235)

Revised: 10/2015
 
IVAX Pharmaceuticals, Inc.