Famotidine

Manufacturer
Fred's, Inc. | Aurohealth LLC | APL HEALTHCARE LIMITED | Aurobindo Pharma Limited
Effective date
2025-04-23
Label type
Human OTC Drug Label
Version
5
Source
full-release
Hydrated at
2026-06-01 00:59:43

Label at a glance#

ProductFamotidine
Active ingredientFAMOTIDINE
Label structure16 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

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 keep the carton. It contains important information. store at 20° to 25°C (68° to 77°F) protect from moisture

Label contents#

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: 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.
  • if you have kidney disease, except under the advice and supervision of a 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 

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION


ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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

Inactive ingredients

INACTIVE INGREDIENT SECTION


carnauba wax, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, red iron oxide, sodium starch glycolate, talc, titanium dioxide and yellow iron oxide.

Questions or comments?

OTC - QUESTIONS SECTION


call 1-855-274-4122

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


JUST ONE TABLET prevents and relieves heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages.

Do not use if carton is open or if printed foil seal under bottle cap is open or torn.

Distributed by: Fred's Inc
4300 New Getwell Road
Memphis, TN 38118
www.fredsinc.com

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (25 Tablets Container Label)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fred's
Pharmacy


NDC 55315-435-53
MAXIMUM STRENGTH
Acid Reducer
Famotidine
Tablets USP 20 mg

Just One Tablet!

Prevents & Relieves
Heartburn Due to
Acid Indigestion


25 Tablets


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (25 Tablets Container Label)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (25 Tablets Container Label)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (25 Tablets Container Carton Label)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

fred's
Pharmacy


NDC 55315-435-53
*Compare to the Active Ingredient in:
Maximum Strength Pepcid® AC

MAXIMUM STRENGTH
Acid Reducer
Famotidine
Tablets USP 20 mg

Just One Tablet!

Prevents & Relieves
Heartburn Due to
Acid Indigestion


25 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (25 Tablets Container Carton Label)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (25 Tablets Container Carton Label)






DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310273famotidine 20 MG Oral TabletPSN5
310273famotidine 20 MG Oral TabletSCD5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
FAMOTIDINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55315-435-53Famotidine1 in 1 CARTONTABLET, FILM COATED15
55315-435-53Famotidine25 in 1 BOTTLETABLET, FILM COATED255

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55315-435FAMOTIDINE TABLET, FILM COATED [FRED'S, INC.]5Current NDC, Legacy NDC, 2 package rows20250426_81b105a1-01fe-51d7-e053-2991aa0a71bc.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55315-43555315-435-53

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206531-001FAMOTIDINEFAMOTIDINE10MGTABLET / ORAL2016-04-26
A206531-002FAMOTIDINEFAMOTIDINE20MGTABLET / ORAL2016-04-26

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-2684e616aacf4f…
2026-09-14 22:38:342026-08A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-2684e616aacf4f…
2026-08-18 06:07:402026-07A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-26caaa826d4ba7…
2026-08-18 06:07:402026-07A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-2674a2ff9319b5…

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
FamotidineFAMOTIDINEFred's, Inc.81b105a1-01fe-51d7-e053-2991aa0a71bc2025-04-23WarningsExact identifier
ndc (package): 55315-435-53
ndc (product): 55315-435
ndc11 (package): 55315043553
spl id: 8dd0ce14-1eb8-4c4a-9f4a-2671fabfa7c0
spl set id: 81b105a1-01fe-51d7-e053-2991aa0a71bc

Reported adverse events (FAERS/openFDA)#

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