Famotidine Tablet, Film Coated [Teva Pharmaceuticals Usa, Inc.] -

FAMOTIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]
PDF | XML

NDC	0093-2748-65, 0093-2748-92, 0093-2748-94
Set ID	2a8cc600-4995-4279-b169-206d7ef8a93f
Category	HUMAN OTC DRUG LABEL
Packager	Teva Pharmaceuticals USA, Inc.
Generic Name
Product Class
Product Number
Application Number	ANDA075512

View All Sections

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0093-2748-65	3 in 1 CARTON	01/08/2015	11/26/2021
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:0093-2748-92	5 in 1 CARTON	01/08/2015	11/26/2021
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:0093-2748-94	7 in 1 CARTON	01/08/2015	11/26/2021
3		10 in 1 BLISTER PACK; Type 0: Not a Combination Product