ORIGINAL STRENGTH HEARTBURN PREVENTION- famotidine tablet 
KROGER COMPANY

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719R_Kroger_41226-719_Famotidine Tablets USP 10 mg

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 right away. (1-800-222-1222)

Directions

-to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.

-to prevent symptoms, swallow 1 tablet with a glass of water at any time from 15 to 60 minutes before eating food or drinking beverages that cause heartburn

-do not use more than 2 tablets in 24 hours

Other information

Inactive ingredients carnauba wax, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, red iron oxide, talc, titanium dioxide

Questions or comments?Call 1-800-632-6900

719R_Kroger_41226-719_Famotidine Tablets USP 10 mg

ORIGINAL STRENGTH HEARTBURN PREVENTION 
famotidine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41226-719
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE10 mg
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TALC (UNII: 7SEV7J4R1U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorpinkScoreno score
ShapeSQUARESize7mm
FlavorImprint Code 86
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41226-719-063 in 1 CARTON05/05/2023
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21754305/05/2023
Labeler - KROGER COMPANY (006999528)
Registrant - TIME CAP LABORATORIES, INC. (037052099)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LIMITED925822975manufacture(41226-719)

Revised: 5/2023
Document Id: fab3c321-167d-50cd-e053-6294a90a054a
Set id: ea1c2838-acbd-18e0-e053-2a95a90a3522
Version: 2
Effective Time: 20230505
 
KROGER COMPANY