FAMOTIDINE

Manufacturer
Ascent Pharmaceuticals, Inc.
Effective date
2022-02-14
Label type
Human OTC Drug Label
Version
3
Source
full-release
Hydrated at
2026-05-31 23:48:19

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

For Famotidine 10 mg: 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  15 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 For Famotidine 20 mg: adults and chil...

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

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Famotidine USP, 10 mg/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.
  • 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

For Famotidine 10 mg:

  • 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 15 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

For Famotidine 20 mg:

  • 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, talc, and titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Please call Ascent Pharmaceuticals, Inc. at 1-855-221-1622 (toll-free number)

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton-10 mgCarton-10 mg

Carton-20 mgCarton-20 mg

CL-10 mgCL-10 mg

CL-20 mgCL-20 mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199047famotidine 10 MG Oral TabletPSN3
310273famotidine 20 MG Oral TabletPSN3
199047famotidine 10 MG Oral TabletSCD3
310273famotidine 20 MG Oral TabletSCD3

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
43602-511-03FAMOTIDINE300 in 1 BOTTLETABLET3003
43602-511-03FAMOTIDINE1 in 1 CARTONTABLET13
43602-511-30FAMOTIDINE30 in 1 BOTTLETABLET303
43602-511-30FAMOTIDINE1 in 1 CARTONTABLET13
43602-602-03FAMOTIDINE1 in 1 CARTONTABLET13
43602-602-03FAMOTIDINE300 in 1 BOTTLETABLET3003
43602-602-30FAMOTIDINE30 in 1 BOTTLETABLET303
43602-602-30FAMOTIDINE1 in 1 CARTONTABLET13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43602-511FAMOTIDINE TABLET [ASCENT PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 4 package rows20220218_b481dd30-7d64-43ec-85d4-2289db62cad7.zip
43602-602FAMOTIDINE TABLET [ASCENT PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 4 package rows20220218_b481dd30-7d64-43ec-85d4-2289db62cad7.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43602-51143602-511-30, 43602-511-03
43602-60243602-602-30, 43602-602-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 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 44.

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
A216030-001FAMOTIDINEFAMOTIDINE10MGTABLET / ORAL2021-11-03
A216030-002FAMOTIDINEFAMOTIDINE20MGTABLET / ORAL2021-11-03

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 · 72 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A216030-001FAMOTIDINE10MGTABLET / ORAL2021-11-03c2088c7a36db…
2026-10-15 13:18:302026-09A216030-002FAMOTIDINE20MGTABLET / ORAL2021-11-03c2088c7a36db…
2026-09-14 22:38:342026-08A216030-001FAMOTIDINE10MGTABLET / ORAL2021-11-0384e616aacf4f…
2026-09-14 22:38:342026-08A216030-002FAMOTIDINE20MGTABLET / ORAL2021-11-0384e616aacf4f…
2026-08-18 06:07:402026-07A216030-001FAMOTIDINE10MGTABLET / ORAL2021-11-03caaa826d4ba7…
2026-08-18 06:07:402026-07A216030-002FAMOTIDINE20MGTABLET / ORAL2021-11-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216030-001FAMOTIDINE10MGTABLET / ORAL2021-11-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216030-002FAMOTIDINE20MGTABLET / ORAL2021-11-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216030-001FAMOTIDINE10MGTABLET / ORAL2021-11-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216030-002FAMOTIDINE20MGTABLET / ORAL2021-11-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A216030-001FAMOTIDINE10MGTABLET / ORAL2021-11-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216030-002FAMOTIDINE20MGTABLET / ORAL2021-11-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216030-001FAMOTIDINE10MGTABLET / ORAL2021-11-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216030-002FAMOTIDINE20MGTABLET / ORAL2021-11-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216030-001FAMOTIDINE10MGTABLET / ORAL2021-11-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216030-002FAMOTIDINE20MGTABLET / ORAL2021-11-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216030-001FAMOTIDINE10MGTABLET / ORAL2021-11-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216030-002FAMOTIDINE20MGTABLET / ORAL2021-11-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216030-001FAMOTIDINE10MGTABLET / ORAL2021-11-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216030-002FAMOTIDINE20MGTABLET / ORAL2021-11-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216030-001FAMOTIDINE10MGTABLET / ORAL2021-11-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216030-002FAMOTIDINE20MGTABLET / ORAL2021-11-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216030-001FAMOTIDINE10MGTABLET / ORAL2021-11-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216030-002FAMOTIDINE20MGTABLET / ORAL2021-11-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216030-001FAMOTIDINE10MGTABLET / ORAL2021-11-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A216030-002FAMOTIDINE20MGTABLET / ORAL2021-11-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216030-001FAMOTIDINE10MGTABLET / ORAL2021-11-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216030-002FAMOTIDINE20MGTABLET / ORAL2021-11-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216030-001FAMOTIDINE10MGTABLET / ORAL2021-11-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216030-002FAMOTIDINE20MGTABLET / ORAL2021-11-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216030-001FAMOTIDINE10MGTABLET / ORAL2021-11-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216030-002FAMOTIDINE20MGTABLET / ORAL2021-11-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216030-001FAMOTIDINE10MGTABLET / ORAL2021-11-038072bd15b7f6…
2024-05-31 18:47 UTC2024-05A216030-002FAMOTIDINE20MGTABLET / ORAL2021-11-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A216030-001FAMOTIDINE10MGTABLET / ORAL2021-11-035c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A216030-002FAMOTIDINE20MGTABLET / ORAL2021-11-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A216030-001FAMOTIDINE10MGTABLET / ORAL2021-11-035d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A216030-002FAMOTIDINE20MGTABLET / ORAL2021-11-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A216030-001FAMOTIDINE10MGTABLET / ORAL2021-11-034b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A216030-002FAMOTIDINE20MGTABLET / ORAL2021-11-034b0b4de00fa7…

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
FAMOTIDINEFAMOTIDINEAscent Pharmaceuticals, Inc.b481dd30-7d64-43ec-85d4-2289db62cad72022-02-14WarningsExact identifier
ndc (package): 43602-602-30
ndc (package): 43602-602-03
ndc (package): 43602-511-30
ndc (package): 43602-511-03
ndc (product): 43602-602
ndc (product): 43602-511
ndc11 (package): 43602060203
ndc11 (package): 43602051130
ndc11 (package): 43602051103
ndc11 (package): 43602060230
spl id: a2adad08-283e-4617-b3db-1eade7f5b296
spl set id: b481dd30-7d64-43ec-85d4-2289db62cad7

Reported adverse events (FAERS/openFDA)#

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