FAMOTIDINE - famotidine tablet, film coated 
Fred's, Inc.

----------


Drug Facts

Active ingredient (in each tablet)

Famotidine USP 20 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


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, titanium dioxide and yellow iron oxide.

Questions or comments?


call 1-855-274-4122

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: Fred's Inc
4300 New Getwell Road
Memphis, TN 38118
www.fredsinc.com

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

Fred's
Pharmacy


NDC 55315-435-53
MAXIMUM STRENGTH
Acid Reducer
Famotidine
Tablets USP 20 mg

Just One Tablet!

Prevents & Relieves
Heartburn Due to
Acid Indigestion


25 Tablets


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

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

fred's
Pharmacy


NDC 55315-435-53
*Compare to the Active Ingredient in:
Maximum Strength Pepcid® AC

MAXIMUM STRENGTH
Acid Reducer
Famotidine
Tablets USP 20 mg

Just One Tablet!

Prevents & Relieves
Heartburn Due to
Acid Indigestion


25 Tablets

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






FAMOTIDINE 
famotidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-435
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE20 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)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
ColorYELLOWScoreno score
ShapeROUND (Square shaped Biconvex) Size5mm
FlavorImprint Code CC;59
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55315-435-531 in 1 CARTON04/26/2016
125 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20653104/26/2016
Labeler - Fred's, Inc. (005866116)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650844777ANALYSIS(55315-435) , MANUFACTURE(55315-435)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(55315-435) , MANUFACTURE(55315-435)

Revised: 12/2021
Document Id: 0dbe885f-b1f6-4401-a14f-ebdd9511b515
Set id: 81b105a1-01fe-51d7-e053-2991aa0a71bc
Version: 4
Effective Time: 20211224
 
Fred's, Inc.