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)

NDC 58602-829-50
PrimaryHealth
See New Warnings
Acid Reducer
MAXIMUM STRENGTH

Famotidine
Tablets USP 20 mg

Just One Tablet!

Prevents & Relieves Heartburn
Due to Acid Indigestion

85 Tablets
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -20 mg (100 Tablets, Container Label)



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

NDC 58602-829-50
PrimaryHealth
*COMPARE TO Maximum
Strength Pepcid® AC
Active Ingredient
See New Warnings
MAXIMUM STRENGTH
Acid Reducer
Famotidine
Tablets USP 20 mg

Just One Tablet!

Prevents & Relieves
Heartburn Due to
Acid Indigestion
Actual Size
85 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -20 mg (100 Tablets, Container Carton Label)






FAMOTIDINE 
famotidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-829
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:58602-829-211 in 1 CARTON04/26/2016
1100 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:58602-829-501 in 1 CARTON03/02/2021
285 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:58602-829-341 in 1 CARTON03/25/2021
3200 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 - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650844777ANALYSIS(58602-829) , MANUFACTURE(58602-829)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(58602-829) , MANUFACTURE(58602-829)

Revised: 12/2021
Document Id: 2c754c84-0a16-4a5c-8ba7-9abbb780eeb4
Set id: 5b161f25-c578-4ff4-a931-ff3a1e681c50
Version: 8
Effective Time: 20211224
 
Aurohealth LLC