FAMOTIDINE - famotidine tablet, film coated 
Magno-Humphries, 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


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

• read the directions and warnings before use
• store at 20° to 25°C (68° to 77°F)
• protect from moisture

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 1-800-935-6737


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 printed foil seal under bottle cap is open or torn.

Distributed by:
Magno-Humphries Labs
Tigard, OR 97223, U.S.A.
Visit our website: www.magno-humphries.com


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


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

MHL℗

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

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)

FAMOTIDINE 
famotidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54257-180
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:54257-180-0790 in 1 BOTTLE; Type 0: Not a Combination Product04/26/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20653104/26/2016
Labeler - Magno-Humphries, Inc. (063251433)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650844777ANALYSIS(54257-180) , MANUFACTURE(54257-180)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(54257-180) , MANUFACTURE(54257-180)

Revised: 12/2021
Document Id: 7353dcda-daf1-4b00-992b-d4855477f666
Set id: ed32f72a-e220-440f-a74f-b754a313f004
Version: 5
Effective Time: 20211224
 
Magno-Humphries, Inc.