FAMOTIDINE - famotidine tablet, film coated 
C.D.M.A., 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

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 800-935-2362


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: C.D.M.A., Inc.©
43157 W 9 Mile Rd
Novi, MI 48375
www.qualitychoice.com
Questions: 800-935-2362

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


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

QC®
QUALITY CHOICE

NDC 63868-563-60
See New Warnings
Original Strength
Acid Controller
Famotidine Tablets USP
10 mg
Acid Reducer
Just One Tablet!

Prevents & Relieves Heartburn
Due to Acid Indigestion  

30 Tablets   

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 MG (30 TABLETS CONTAINER LABEL)

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

QC®
QUALITY CHOICE

NDC 63868-563-60
*Compare to the
Active Ingredient in
Original Strength Pepcid® AC
See New Warnings
Original Strength
Acid Controller
Famotidine Tablets USP
10 mg

Acid Reducer
Just One Tablet!

Prevents & Relieves Heartburn
Due to Acid Indigestion

30 Tablets      actual size

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:63868-563
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:63868-563-601 in 1 CARTON08/20/2019
130 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20653108/20/2019
Labeler - C.D.M.A., Inc. (011920774)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(63868-563) , MANUFACTURE(63868-563)

Revised: 7/2020
Document Id: 196f1876-f7ae-42bc-94fe-743ba9c6bb28
Set id: b8beac67-b20c-4c45-aebd-63351ac73b7b
Version: 4
Effective Time: 20200713
 
C.D.M.A., Inc.