FAMOTIDINE - famotidine tablet, film coated 
Aurohealth LLC

----------


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 1-855-274-4122

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
2572 Brunswick Pike
Lawrenceville, NJ 08648

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

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

NDC 58602-828-19
PrimaryHealth
See New Warnings
Acid Reducer
ORIGINAL STRENGTH
Famotidine
Tablets USP 10 mg

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)

NDC 58602-828-19
PrimaryHealth

*COMPARE TO Original
Strength Pepcid® AC
Active Ingredient 
See New Warnings
Acid Reducer
ORIGINAL STRENGTH
Famotidine
Tablets USP 10 mg

Just One Tablet!

Prevents & Relieves
Heartburn Due to
Acid Indigestion

Actual Size

90 Tablets

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



FAMOTIDINE 
famotidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-828
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:58602-828-191 in 1 CARTON04/26/2016
190 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(58602-828) , MANUFACTURE(58602-828)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(58602-828) , MANUFACTURE(58602-828)

Revised: 12/2021
Document Id: 1ad81b32-80e7-438c-a998-f22c7bd94448
Set id: 27ecf5c1-202a-44cf-94f9-d7fefa027e1e
Version: 5
Effective Time: 20211224
 
Aurohealth LLC