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

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Drug Facts

Active ingredient (in each tablet)

Famotidine USP 10 mg

Purpose

Acid reducer

Uses


Warnings


Allergy alert: Do not use if you are allergic to famotidine or other acid reducers

Do not use


Ask a doctor before use if you have

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


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


Other information


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

 

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)

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

famotidine-fig2.jpg



FAMOTIDINE 
famotidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-589
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE10 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
STARCH, CORN (UNII: O8232NY3SJ)  
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorPINKScoreno score
ShapeROUND (biconvex) Size5mm
FlavorImprint Code CC;58
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49035-589-191 in 1 CARTON06/24/2020
190 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:49035-589-771 in 1 CARTON01/21/2021
230 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20653106/24/2020
Labeler - Wal-Mart Stores, Inc. (051957769)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650844777ANALYSIS(49035-589) , MANUFACTURE(49035-589)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(49035-589) , MANUFACTURE(49035-589)

Revised: 2/2022
Document Id: cf5fa8a1-32c4-4e85-a4a9-a9cf1f55654c
Set id: 018b02e8-1005-4736-a4fc-962881f52adf
Version: 6
Effective Time: 20220211
 
Wal-Mart Stores, Inc.