Famotidine

Label at a glance#

Contacts and useful links#

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Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Famotidine, USP 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 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

STORAGE AND HANDLING SECTION

• read the directions and warnings before use
• store at 20° to 25° C (68° to 77° F)
• protect from moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, talc, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

Call toll-free Monday-Friday 8:30 am to 5 pm EST at 1800-406-7984.

SPL UNCLASSIFIED SECTION

Distributed By: AmerisourceBergen,
1300 Morris Drive, Chesterbrook, PA 19087

PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 46122-168-78

GOOD
NEIGHBOR
PHARMACY^®

^†Compare to the active ingredient of
Maximum Strength Pepcid AC^®

famotidine tablets, USP 20 mg

Acid Reducer

Maximum Strength

Just One Tablet
Prevents & Relieves Heartburn
Due to Acid Indigestion

100 tablets

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Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

• Famotidine
• SILICON DIOXIDE
• HYDROXYPROPYL CELLULOSE (1600000 WAMW)
• HYPROMELLOSE, UNSPECIFIED
• MAGNESIUM STEARATE
• MICROCRYSTALLINE CELLULOSE
• POLYETHYLENE GLYCOL 400
• STARCH, CORN
• TALC
• TITANIUM DIOXIDE

NDC Codes#

Ingredients#

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DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

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Inactive ingredient links page 1 of 6 · 303 matching rows.

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Orange Book application contexts page 1 of 1 · 1 matching rows.

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

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 86 observed states.

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Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.