FAMOTIDINE 10 MG tablet, coated FAMOTIDINE 20 MG tablet, coated

Famotidine 20 mg by

Drug Labeling and Warnings

Famotidine 20 mg by is a Otc medication manufactured, distributed, or labeled by MARKSANS PHARMA LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

For 10 mg:

Famotidine USP 10 mg

For 20 mg:

Famotidine USP 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

For 10mg:

 adults and children 12 years and over:
o to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
o 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
o do not use more than 2 tablets in 24 hours
 children under 12 years: ask a doctor

For 20 mg:

 adults and children 12 years and over:
o to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
o 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
o 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°-25°C (68°-77°F)
 protect from moisture
FDA approved dissolution test specifications differ from USP

Inactive ingredients

For 10 mg:

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

For 20 mg:

carnauba wax, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc, titanium dioxide

Questions or comments?

Call 1-877-376-4271 (weekdays 9 AM to 5 PM)

• JUST ONE TABLET prevents and relieves heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages.

Tips for Managing Heartburn
 Do not lie flat or bend over after eating
 Do not wear tight-fitting clothing around the stomach
 Do not eat before bedtime
 Raise the head of your bed
 Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol, and certain fruits and vegetables
 Eat slowly and avoid big meals
 If overweight, lose weight
 Quit smoking

Manufactured for:
Time-Cap Labs, Inc.
7 Michael Avenue,
Farmingdale,
NY 11735, USA

Manufactured by:
Marksans Pharma Ltd.
Plot No. L-82, L-83
Verna Indl. Estate
Verna, Goa-403722, India 

PRINCIPAL DISPLAY PANEL

Famotidine Tablets USP, 10 mg

NDC: 25000-086-36

Famotidine Tablets USP 10 mg

30's (3 x 10's blister) count Carton Label

NDC: 25000-086-03

Famotidine Tablets USP 10 mg

30's count Bottle Label

NDC: 25000-086-03

Famotidine Tablets USP 10 mg

30's count Carton Label

NDC: 25000-086-08

Famotidine Tablets USP 10 mg

100's count Bottle Label

NDC: 25000-086-08

Famotidine Tablets USP 10 mg

100's count Carton Label

Famotidine Tablets USP, 20 mg

NDC: 25000-087-36

Famotidine Tablets USP 20 mg

30's (3 x 10's blister) count Carton Label

NDC: 25000-087-03

Famotidine Tablets USP 20 mg

30's count Bottle Label

NDC: 25000-087-03

Famotidine Tablets USP 20 mg

30's count Carton Label

NDC: 25000-087-08

Famotidine Tablets USP 20 mg

100's count Bottle Label

NDC: 25000-087-08

Famotidine Tablets USP 20 mg

100's count Carton Label

INGREDIENTS AND APPEARANCE

FAMOTIDINE 10 MG 
famotidine 10 mg tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 25000-086
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
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)
STARCH, CORN (UNII: O8232NY3SJ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	PINK	Score	no score
Shape	SQUARE	Size	7mm
Flavor		Imprint Code	86
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 25000-086-36	3 in 1 CARTON	03/10/2023
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 25000-086-03	1 in 1 CARTON	03/10/2023
2		30 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 25000-086-08	1 in 1 CARTON	03/10/2023
3		100 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	ANDA217543	03/10/2023

FAMOTIDINE 20 MG 
famotidine 20 mg tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 25000-087
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
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	SEMI-CIRCLE (D-shaped)	Size	9mm
Flavor		Imprint Code	87
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 25000-087-36	3 in 1 CARTON	03/10/2023
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 25000-087-03	1 in 1 CARTON	03/10/2023
2		30 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 25000-087-08	1 in 1 CARTON	03/10/2023
3		100 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	ANDA217543	03/10/2023

Labeler - MARKSANS PHARMA LIMITED (925822975)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		925822975	MANUFACTURE(25000-086, 25000-087)