FDA.reportPublic FDA data

Famotidine Tablet

Manufacturer
Praxis, LLC
Effective date
2023-01-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:56:32

Label at a glance#

ProductFamotidine
Active ingredientFAMOTIDINE
Label structure13 sections

Indications and 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

Dosage and administration

Use as directed per healthcare professional. 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

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

20 mg

For Hospital Use Only

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Famotidine 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 aretaking 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

  • Use as directed per healthcare professional.
  • adults and children 12 years and over:
    • to relievesymptoms, swallow 1 tablet with a glass of water. Do not chew.
    • to preventsymptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes beforeeating 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°-25°C (68°-77°F)
  • protect from moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-397-9228

SPL UNCLASSIFIED SECTION

GLUTEN FREE

How Supplied

HOW SUPPLIED SECTION

NDC 68094-054-65
Unit Dose Packages of 200 Tablets
(20 × 10) per Carton

SPL UNCLASSIFIED SECTION

Packaged by:
Precision Dose, Inc.
South Beloit, IL 61080

For inquiries call Precision Dose, Inc.
at 1-800-397-9228 or email
druginfo@precisiondose.com

LI1465 Rev. 08/23

PRINCIPAL DISPLAY PANEL - 20 mg Tablet Blister Pack Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Precision Dose™

NDC 68094-054-65
Unit Dose

Famotidine
Tablets 20 mg

200 Tablets
(20 x 10)
(in each tablet)
Famotidine 20 mg
Acid reducer

Directions
To relieve symptoms, swallow 1 tablet
with a glass of water. Do not chew.

GLUTEN FREE

USUAL DOSE: SEE ENCLOSED DRUG FACTS

Store at 20°-25°C (68°-77°F)
protect from moisture

Keep out of reach of children.
Hospital Use Only.

LC1464
R1

Packaged by:
Precision Dose, Inc.
South Beloit, IL 61080

PRINCIPAL DISPLAY PANEL - 20 mg Tablet Blister Pack Carton Label
PRINCIPAL DISPLAY PANEL - 20 mg Tablet Blister Pack Carton Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
396bde5c-c78e-2f8b-ab1f-2ee6ba32bcaeProduct name720260317
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
cf645750-2e70-f6e1-c05a-a52847def5ddProduct name920250312
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59368-280FAMOTIDINE TABLET, FILM COATED [PRAXIS, LLC]1Unmatched20250305_2f73ec98-c2c3-7acd-e063-6294a90a49d9.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59368-28059368-280-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARNAUBA WAXR12CBM0EIZIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FAMOTIDINE5QZO15J2Z8ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3ed9af4e-f77d-49df-e063-6294a90a60082f73ec98-c2c3-7acd-e063-6294a90a49d92025-09-15WarningsExact identifier
spl set id: 2f73ec98-c2c3-7acd-e063-6294a90a49d9

Reported adverse events (FAERS/openFDA)#

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