FAMOTIDINE by Ascent Pharmaceuticals, Inc. FAMOTIDINE tablet

FAMOTIDINE by

Drug Labeling and Warnings

FAMOTIDINE by is a Otc medication manufactured, distributed, or labeled by Ascent Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Famotidine USP, 10 mg/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 DOCTOR/PHARMACIST

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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:

• adults and children 12 years and over: 
• 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
• children under 12 years: ask a doctor

For Famotidine 20 mg:

• adults and children 12 years and over:
• 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 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°-25°C (68°-77°F)
• protect from moisture

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)

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FAMOTIDINE 
famotidine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43602-511
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
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
Color	white	Score	no score
Shape	ROUND	Size	5mm
Flavor		Imprint Code	T;511
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43602-511-30	1 in 1 CARTON	11/03/2021
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 43602-511-03	1 in 1 CARTON	11/03/2021
2		300 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	ANDA216030	11/03/2021

FAMOTIDINE 
famotidine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43602-602
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
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
Color	white	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	T;602
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43602-602-30	1 in 1 CARTON	11/03/2021
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 43602-602-03	1 in 1 CARTON	11/03/2021
2		300 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	ANDA216030	11/03/2021

Labeler - Ascent Pharmaceuticals, Inc. (080938961)

Establishment
Name	Address	ID/FEI	Business Operations
Ascent Pharmaceuticals, Inc.		080938961	manufacture(43602-511, 43602-602) , analysis(43602-511, 43602-602) , pack(43602-511, 43602-602)