FAMOTIDINE - famotidine tablet, film coated 
Aurohealth LLC

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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


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, 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: AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520

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

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -20 mg (85 Tablets, Container Label)

Healthy Living
See New Warnings
Maximum Strength
FAMOTIDINE
tablets USP 20 mg

Acid Reducer
Just One Tablet!

Prevents & Relieves Heartburn
Due to Acid Indigestion

85 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -20 mg (50 Tablets, Container Label)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -20 mg (85 Tablets, Container Carton Label)

Healthy Living

See New Warnings
Maximum Strength

FAMOTIDINE
tablets USP 20 mg

Acid Reducer
Just One Tablet!

*Compare
to the Active
Ingredient of
Maximum Strength
Pepcid®
AC

Prevents & Relieves Heartburn
Due to Acid Indigestion

85 Tablets                       Actual Size



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -20 mg (200 Tablets, Container Carton Label)









FAMOTIDINE 
famotidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-859
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:58602-859-501 in 1 CARTON03/02/2021
185 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:58602-859-341 in 1 CARTON03/02/2021
2200 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20653103/02/2021
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650844777ANALYSIS(58602-859) , MANUFACTURE(58602-859)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(58602-859) , MANUFACTURE(58602-859)

Revised: 3/2022
Document Id: f2f76f8d-f875-4087-9a92-1fe36c5d3e44
Set id: 6d0d8839-0680-45f6-96db-2d8edc9d4682
Version: 5
Effective Time: 20220310
 
Aurohealth LLC