Famotidine Tablets

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Famotidine, USP 10 mg and 20 mg

Purpose

OTC - PURPOSE SECTION

Acid reducer

Uses

INDICATIONS & USAGE SECTION

• 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

WARNINGS SECTION

Allergy alert

SPL UNCLASSIFIED SECTION

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

Do not use

OTC - DO NOT USE SECTION

• 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

OTC - ASK DOCTOR SECTION

• 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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

• 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 (of 10 mg) with a glass of water at any time from 15 to 60 minutes before eating food or drinking beverages that cause heartburn
  • to prevent symptoms, swallow 1 tablet (of 20 mg) with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn
  • 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Microcrystalline Cellulose, Pre-gelatinized Starch, Sodium Starch glycolate, Hydroxypropyl Cellulose, Magnesium stearate, Hypromellose, Titanium dioxide, Triacetin, Talc, Macrogol

Questions or comments?

OTC - QUESTIONS SECTION

Call us at 1 (888) 721-7115 (toll-free)

SPL UNCLASSIFIED SECTION

Distributed by: MIDWOOD BRANDS, LLC

500 Volvo Pkwy, Chesapeake, Va 23320 USA
Product of India
M.L. No.: 02/SKL/AP/2015/F/R

Revision: 06/25

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 55319-408-01

Famotidine Tablets, USP 10mg

60 Tablets

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 55319-409-03

Famotidine Tablets, USP 20mg

100 Tablets

DailyMed RxNorm Mappings#

DailyMed Pharmacologic Classes#

DailyMed Product Concepts#

DailyMed Package Descriptions#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

• Famotidine
• MICROCRYSTALLINE CELLULOSE
• STARCH, CORN
• SODIUM STARCH GLYCOLATE TYPE A
• HYDROXYPROPYL CELLULOSE (110000 WAMW)
• MAGNESIUM STEARATE
• HYPROMELLOSE 2910 (6 MPA.S)
• TITANIUM DIOXIDE
• TRIACETIN
• POLYETHYLENE GLYCOL 4000
• TALC

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Source Document#

Source XML

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Current product rows page 1 of 1 · 2 matching rows.

Observed Orange Book product history#

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Product history page 1 of 2 · 68 observed states.

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Reported adverse events (FAERS/openFDA)#

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