FAMOTIDINE tablet, film coated

Famotidine by

Drug Labeling and Warnings

Famotidine by is a Otc medication manufactured, distributed, or labeled by LEADER/ Cardinal Health 110, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient(in each tablet)
Famotidine 20 mg

PURPOSE

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

• side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
• 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.
• 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

Other information

• read the directions and warnings before use
• store at 20°-25°C (68°-77°F)
• protect from moisture
• meets USP Dissolution Test 2

INACTIVE INGREDIENT

colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide.

QUESTIONS

Questions or comments?

1-800-231-4670:
weekdays 9am-5pm EST

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313

*This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Pepcid AC®.

KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

PRINCIPAL DISPLAY PANEL

NDC: 70000-0710-1

Maximum Strength

Acid Reducer

Famotidine Tablets USP, 20 mg

Just One Tablet Prevents
& Relieves Heartburn Due
to Acid Indigestion

COMPARE TO MAXIMUM STRENGTH PEPCID AC® active ingredient*

200
TABLETS

INGREDIENTS AND APPEARANCE

FAMOTIDINE 
famotidine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0710
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
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TALC (UNII: 7SEV7J4R1U)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	C;29
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0710-1	1 in 1 CARTON	12/04/2024
1		200 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	ANDA218003	12/04/2024

Labeler - LEADER/ Cardinal Health 110, Inc. (063997360)