FAMOTIDINE- famotidine tablet, film coated

famotidine by

Drug Labeling and Warnings

famotidine by is a Otc medication manufactured, distributed, or labeled by Camber Consumer Care Inc, Annora Pharma Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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
 

Famotidine Tablets USP 10 mg - 30s container carton label
   

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

Famotidine Tablets USP 20 mg - 30s container label
 

Famotidine Tablets USP 20 mg - 30s container carton label

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

INGREDIENTS AND APPEARANCE

FAMOTIDINE  
famotidine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69230-326
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8)	FAMOTIDINE	10 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	T;10
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69230-326-30	1 in 1 CARTON	11/08/2021
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 69230-326-60	1 in 1 CARTON	11/08/2021
2		60 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 69230-326-01	1 in 1 CARTON	11/08/2021
3		100 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 69230-326-05	1 in 1 CARTON	11/08/2021
4		500 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 69230-326-10	1 in 1 CARTON	11/08/2021
5		1000 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA215766	11/08/2021

FAMOTIDINE  
famotidine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69230-327
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8)	FAMOTIDINE	20 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	yellow (LIGHT YELLOW)	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	T;11
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69230-327-30	1 in 1 CARTON	11/08/2021
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 69230-327-50	1 in 1 CARTON	11/08/2021
2		50 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 69230-327-01	1 in 1 CARTON	11/08/2021
3		100 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 69230-327-05	1 in 1 CARTON	11/08/2021
4		500 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 69230-327-10	1 in 1 CARTON	11/08/2021
5		1000 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA215766	11/08/2021

Labeler - Camber Consumer Care Inc (079539968)

Establishment
Name	Address	ID/FEI	Business Operations
Annora Pharma Private Limited		650980746	analysis(69230-326, 69230-327) , manufacture(69230-326, 69230-327)