FAMOTIDINE - famotidine tablet, film coated 
Camber Consumer Care Inc

----------

Famotidine tablets USP, 10 mg and 20 mg

Active ingredient (in each tablet)

Famotidine USP 10 mg and 20 mg

Purpose

Acid reducer

Uses

• relieves heartburn associated with acid indigestion and sour stomach
• prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages

Warnings

Allergy alert: Do not use if you are allergic to famotidine or other acid reducers

Do not use


• if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
• with other acid reducers

Ask a doctor before use if you have

• had heartburn over 3 months. This may be a sign of a more serious condition.
• heartburn with lightheadedness, sweating, or dizziness
• chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
• frequent chest pain
• frequent wheezing, particularly with heartburn
• unexplained weight loss
• nausea or vomiting
• stomach pain
• kidney disease

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

• your heartburn continues or worsens
• you need to take this product for more than 14 days

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

• adults and children 12 years and over:
• to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.

10 mg:
• 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

20 mg:

• to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn
• do not use more than 2 tablets in 24 hours
• children under 12 years: ask a doctor

Other information

• read the directions and warnings before use
• keep the carton. It contains important information.
• store at 20° to 25°C (68° to 77°F)
• protect from moisture

Inactive ingredients


corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and film coating contains carnauba wax, hydroxypropyl cellulose, hypromellose, talc, titanium dioxide; and additionally 20 mg contains iron oxide red and iron oxide yellow.

Questions or comments?

1-866-495-1995

PRINCIPAL DISPLAY PANEL


Famotidine Tablets USP 10 mg - 30s container label
 

famotab10mgcontlabel30s-count



Famotidine Tablets USP 10 mg - 30s container carton label
   

famotab10mgcontlabel30scontcarton


Famotidine Tablets USP 10 mg - 10 (1x10) blister carton label
 

famotab10mgcontlabel100scontcarton



Famotidine Tablets USP 20 mg - 30s container label
 

famotab20mgcontlabel-30scount



Famotidine Tablets USP 20 mg - 30s container carton label


famotab20mgcontlabel-30scontcarton



Famotidine Tablets USP 20 mg - 10 (1x10) blister carton label

famotab20mgcontlabel100s-contcarton

FAMOTIDINE  
famotidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69230-326
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE10 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TALC (UNII: 7SEV7J4R1U)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize6mm
FlavorImprint Code T;10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69230-326-301 in 1 CARTON11/08/2021
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:69230-326-601 in 1 CARTON11/08/2021
260 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:69230-326-011 in 1 CARTON11/08/2021
3100 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:69230-326-051 in 1 CARTON11/08/2021
4500 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:69230-326-101 in 1 CARTON11/08/2021
51000 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21576611/08/2021
FAMOTIDINE  
famotidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69230-327
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE20 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TALC (UNII: 7SEV7J4R1U)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
Coloryellow (LIGHT YELLOW) Scoreno score
ShapeROUNDSize6mm
FlavorImprint Code T;11
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69230-327-301 in 1 CARTON11/08/2021
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:69230-327-501 in 1 CARTON11/08/2021
250 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:69230-327-011 in 1 CARTON11/08/2021
3100 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:69230-327-051 in 1 CARTON11/08/2021
4500 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:69230-327-101 in 1 CARTON11/08/2021
51000 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21576611/08/2021
Labeler - Camber Consumer Care Inc (079539968)
Establishment
NameAddressID/FEIBusiness Operations
Annora Pharma Private Limited650980746analysis(69230-326, 69230-327) , manufacture(69230-326, 69230-327)

Revised: 10/2022
Document Id: eabd2ff8-a7d9-2ac4-e053-2995a90a3b40
Set id: ebe3ca30-df25-4c56-8935-414a3431b5b9
Version: 2
Effective Time: 20221011
 
Camber Consumer Care Inc