Famotidine: Package Insert and Label Information

FAMOTIDINE — famotidine tablet, film coated
Wal-Mart Stores, Inc.


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
  • 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 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
  • 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 and titanium dioxide.

Questions or comments?

call 1-888-287-1915

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: Walmart Inc.,
Bentonville, AR 72716

Made in India
Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (90 Tablets Container Label)

SEE NEW WARNINGS
NDC 49035-589-19
equate
ORIGINAL STRENGTH
Famotidine
Tablets USP 10 mg
Acid Reducer
• Just one tablet prevents &
relieves heartburn due to
acid indigestion
90
TABLETS

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (90 Tablets Container Label)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (90 Tablets Container Carton Label)

SEE NEW WARNINGS
NDC 49035-589-19
equate
Compare
to original
Strength
Pepcid® AC
active
ingredient*
ORIGINAL STRENGTH
Famotidine
Tablets USP 10 mg
Acid Reducer
• Just one tablet prevents
and relieves heartburn due to
acid indigestion
10 90
ACTUAL SIZE mg TABLETS

//druginserts.com/lib/images-otc/famotidine-41/famotidine-fig2-300x268.jpg
(click image for full-size original)

FAMOTIDINE famotidine tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-589
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE 10 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX
STARCH, CORN
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE 2910 (5 MPA.S)
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
FERRIC OXIDE RED
SODIUM STARCH GLYCOLATE TYPE A CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color PINK Score no score
Shape ROUND (biconvex) Size 5mm
Flavor Imprint Code CC;58
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49035-589-19 1 BOTTLE in 1 CARTON contains a BOTTLE
1 90 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (49035-589-19)
2 NDC:49035-589-77 1 BOTTLE in 1 CARTON contains a BOTTLE
2 30 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (49035-589-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206531 06/24/2020
Labeler — Wal-Mart Stores, Inc. (051957769)
Registrant — Aurohealth LLC (078728447)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 650381903 ANALYSIS (49035-589), MANUFACTURE (49035-589)

Revised: 01/2021 Wal-Mart Stores, Inc.

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