FAMOTIDINE tablet, film coated

Famotidine by

Drug Labeling and Warnings

Famotidine by is a Otc medication manufactured, distributed, or labeled by Teva Pharmaceuticals USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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. (1-800-222-1222)

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 anytime 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

Principal Display Panel, Part 1 of 2

Principal Display Panel, Part 2 of 2

Famotidine Tablets USP 10 mg Acid Reducer, Just One Per Dose, 30s Carton Text

Prevents and Relieves Heartburn Due to Acid Indigestion

NDC 0093-2748-65

Tamper-Evident

Famotidine

Tablets USP

10 mg

ACID REDUCER

30 TABLETS Just One Per Dose

TEVA

INGREDIENTS AND APPEARANCE

FAMOTIDINE 
famotidine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0093-2748
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	ORANGE (PEACH)	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	TEVA;2662
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0093-2748-65	3 in 1 CARTON	01/08/2015
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 0093-2748-92	5 in 1 CARTON	01/08/2015
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 0093-2748-94	7 in 1 CARTON	01/08/2015
3		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075512	01/08/2015

Labeler - Teva Pharmaceuticals USA, Inc. (001627975)