FDA.reportPublic FDA data

Famotidine Tablets 20 mg Drug Facts

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC
Effective date
2020-02-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:03:51

Label at a glance#

ProductBasic Care famotidine
Active ingredientFAMOTIDINE
Label structure9 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°-25°C (68°-77°F) • protect from moisture and light

Label contents#

Full prescribing information#

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: 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 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°-25°C (68°-77°F)
  • protect from moisture and light

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Repackaging Information

SPL UNCLASSIFIED SECTION

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count20 mg
9071610-389-60

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:
Aphena Pharma Solutions - TNAphena Pharma Solutions - TN
Cookeville, TN 38506

20200219JH

PRINCIPAL DISPLAY PANEL - 20 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71610-389 - Famotidine, USP 20 mg Tablets
Bottle Label 20 mgBottle Label 20 mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310273famotidine 20 MG Oral TabletPSN1
310273famotidine 20 MG Oral TabletSCD1

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71610-389-602023-01-30C16284748780-1f386c64a-4282-0266-e053-dadaa90a7c1aFamotidine Tablets 20 mg Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-389-60Basic Care famotidine90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-389BASIC CARE FAMOTIDINE (FAMOTIDINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 1 package rows20200225_bb4ae87b-4fc3-45e5-a81b-f45a934e3776.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
71610-38971610-389-60
0113-7194

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
FAMOTIDINE5QZO15J2Z8ACTIB
CARNAUBA WAXR12CBM0EIZIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL3WJQ0SDW1AIACT
POLYVINYL ALCOHOL532B59J990IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML · Source PDF

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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077351-001FAMOTIDINEFAMOTIDINE20MGTABLET / ORAL2006-09-25

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 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-2584e616aacf4f…
2026-08-18 06:07:402026-07A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-253f01610625f2…
2019-09-15 20:21 UTC2019-09A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077351-001FAMOTIDINE20MGTABLET / ORAL2006-09-25f41ea6bd6efb…

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
752f1109-0554-43c0-ba8b-a8379baadcf9bb4ae87b-4fc3-45e5-a81b-f45a934e37762020-02-19WarningsExact identifier
spl id: 752f1109-0554-43c0-ba8b-a8379baadcf9
spl set id: bb4ae87b-4fc3-45e5-a81b-f45a934e3776

Reported adverse events (FAERS/openFDA)#

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