FAMOTIDINE - famotidine tablet, film coated 
Cardinal Health

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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

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.

Dist. by CAH, Dublin, OH 43017                       
1-800-200-6313
Made in India

©2023 CARDINAL HEALTH, LEADER, and LOGOs are trademarks of Cardinal
Health.
All other marks are the property of their respective owners.
Code: TS/DRUGS/22/2009


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (30 Tablets Container Label)

LEADERTM

NDC 70000-0048-1
Original Strength
Acid Reducer
Famotidine Tablets USP, 10 mg | Acid Reducer

Just One Tablet!
Prevents & Relieves
Heartburn Due to Acid Indigestion  

30 TABLETS                                    100% Money
                                                         Back Guarantee



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

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (30 Tablets Container Carton Label)

LEADERTM

NDC 70000-0048-1
Original Strength
Acid
Reducer
Famotidine Tablets USP, 10 mg
Acid Reducer

Just One Tablet!
Prevents & Relieves Heartburn
Due to Acid Indigestion  

Actual Size                                 COMPARE TO
                                                     ORIGINAL
                                                     STRENGTH
                                                     PEPCID® AC
                                                     active ingredient

30
TABLETS                                    100% Money
                                                     Back Guarantee
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (30 Tablets Container Carton Label)



FAMOTIDINE 
famotidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0048
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:70000-0048-11 in 1 CARTON04/04/2020
130 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20653104/04/2020
Labeler - Cardinal Health (063997360)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650844777ANALYSIS(70000-0048) , MANUFACTURE(70000-0048)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(70000-0048) , MANUFACTURE(70000-0048)

Revised: 7/2023
Document Id: d407f522-787b-455d-920f-2c92b89e3007
Set id: cdd509c4-331b-4aee-935c-dfc44d5943ed
Version: 6
Effective Time: 20230703
 
Cardinal Health