FAMOTIDINE tablet, film coated

United States - English - NLM (National Library of Medicine)

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Active ingredient:
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8)
Available from:
Chain Drug Consortium, LLC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Acid reducer - 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 - 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 - 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  - kidney disease taking a prescription drug. Acid reducers may interact with certain prescription drugs. - your heartburn continues or worsens - you need to take this product for more than 14 days
Authorization status:
Abbreviated New Drug Application
Authorization number:
68016-097-25

FAMOTIDINE - famotidine tablet, film coated

Chain Drug Consortium, LLC

----------

Drug Facts

Active ingredient (in each tablet)

Famotidine USP 20 mg

Purpos e

Acid reducer

Us es

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

kidney disease

Ask a doctor or pharmacist before use if you are

taking a prescription drug. Acid reducers may interact with certain prescription drugs.

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 (1-800-222-1222) 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 10 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

keep the carton. It contains important information.

store at 20° to 25°C (68° to 77°F)

protect from moisture

Inactive ingredients

carnauba wax, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate,

microcrystalline cellulose, red iron oxide, sodium starch glycolate, talc, titanium dioxide and yellow

iron oxide.

Questions or comments?

call 1-855-274-4122

Tips for Managing Heartburn

Do not lie flat or bend over after eating

Do not wear tight-fitting clothing around the stomach

Do not eat before bedtime

Raise the head of your bed

Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine,

alcohol, and certain fruits and vegetables

Eat slowly and avoid big meals

If overweight, lose weight

Quit smoking

JUST ONE TABLET prevents and relieves heartburn due to acid indigestion brought on by eating and

drinking certain foods and beverages.

Do not use if carton is open or if printed foil seal under bottle cap is open or torn.

Distributed By:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

Made in India

Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -20 mg (25 Tablets, Container Label)

Premier Value

See New Warnings

MAXIMUM STRENGTH

Famotidine Tablets USP 20 mg

Acid Controller

Acid Reducer

Just One Tablet!

Prevents & Relieves

Heartburn Due to

Acid Indigestion

25 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -20 mg (25 Tablets, Container Carton

Label)

®

Premier Value

†COMPARE TO THE ACTIVE INGREDIENT

IN MAXIMUM STRENGTH PEPCID AC

See New Warnings

MAXIMUM STRENGTH

Famotidine Tablets USP 20 mg

Acid Controller

Acid Reducer

Just One Tablet!

Prevents & Relieves Heartburn

Due to Acid Indigestion

Actual Size

25 Tablets

®

®

FAMOTIDINE

famotidine tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 8 0 16 -0 9 7

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

FAMO TIDINE (UNII: 5QZO15J2Z8 ) (FAMOTIDINE - UNII:5QZO15J2Z8 )

FAMOTIDINE

20 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CARNAUBA WAX (UNII: R12CBM0 EIZ)

STARCH, CO RN (UNII: O8 232NY3SJ)

HYDRO XYPRO PYL CELLULO SE ( 16 0 0 0 0 0 WAMW) (UNII: RFW2ET6 71P)

HYPRO MELLO SE 2 9 10 ( 5 MPA.S) (UNII: R75537T0 T4)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

Chain Drug Consortium, LLC

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

SO DIUM STARCH GLYCO LATE TYPE A CO RN (UNII: AG9 B6 5PV6 B)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

Product Characteristics

Color

YELLOW

S core

no sco re

S hap e

ROUND (Square shaped Bico nvex)

S iz e

Flavor

Imprint Code

CC;59

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 8 0 16 -0 9 7-25

1 in 1 CARTON

0 8 /16 /20 19

1

25 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 6 531

0 8 /16 /20 19

Labeler -

Chain Drug Consortium, LLC (101668460)

Registrant -

Aurohealth LLC (078728447)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Auro bindo Pharma Limited

6 50 38 19 0 3

ANALYSIS(6 8 0 16 -0 9 7) , MANUFACTURE(6 8 0 16 -0 9 7)

Revised: 7/2020

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