FAMOTIDINE- famotidine tablet 
Ascent Pharmaceuticals, Inc.

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Active ingredient (in each tablet)

Famotidine USP, 10 mg/20 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

For Famotidine 10 mg:

For Famotidine 20 mg:

Other information

Inactive ingredients

Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, talc, and titanium dioxide

Questions or comments?

Please call Ascent Pharmaceuticals, Inc. at 1-855-221-1622 (toll-free number)

Tips for Managing Heartburn

Carton-10 mg

Carton-20 mg

CL-10 mg

CL-20 mg

FAMOTIDINE 
famotidine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43602-511
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE10 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize5mm
FlavorImprint Code T;511
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43602-511-301 in 1 CARTON11/03/2021
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:43602-511-031 in 1 CARTON11/03/2021
2300 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21603011/03/2021
FAMOTIDINE 
famotidine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43602-602
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE20 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize6mm
FlavorImprint Code T;602
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43602-602-301 in 1 CARTON11/03/2021
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:43602-602-031 in 1 CARTON11/03/2021
2300 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21603011/03/2021
Labeler - Ascent Pharmaceuticals, Inc. (080938961)
Establishment
NameAddressID/FEIBusiness Operations
Ascent Pharmaceuticals, Inc.080938961manufacture(43602-511, 43602-602) , analysis(43602-511, 43602-602) , pack(43602-511, 43602-602)

Revised: 2/2022
Document Id: a2adad08-283e-4617-b3db-1eade7f5b296
Set id: b481dd30-7d64-43ec-85d4-2289db62cad7
Version: 3
Effective Time: 20220214
 
Ascent Pharmaceuticals, Inc.