Famotidine

Manufacturer
Little Pharma, Inc.
Effective date
2025-07-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:06:34

Label at a glance#

ProductFamotidine
Active ingredientFAMOTIDINE
Label structure16 sections

Storage and handling

Other Information read the directions and warnings before use store at 20º to 25ºC (68º to 77ºF) protect from moisture

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Tips for Managing Heartburn

  • Do not lie flat or bend over after eating
  • Do not wear tight fitting clothing around th estomach
  • 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

Just One Tablet prevents and relieves heartburn die to acid indigestion brough on by leating and drinking certain foods and beverages

Important: Read all directions and warnings before use. Tamper Evident: Do not use if imprented inner safety seal is torn or missing

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each tablet)

Famotidine USP 10mg

OTC - PURPOSE SECTION

Acid reducer

INDICATIONS & USAGE SECTION

  • relieves heartburn associated with acid indigestion and sour stomach
  • prevents heartburn associated with acid indigestion and sour stomach brough on by eating or drinking certain food and beverages

WARNINGS SECTION

Alergy Alert

Do not us if allergic to Famotidine or other acid reducers

OTC - DO NOT USE SECTION

Do Not Use

  • 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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • 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.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • 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 Contol Center right away. (1-800-222-1222)

DOSAGE & ADMINISTRATION SECTION

Directions

  • adults and children 12 years and over:
  • to relieve symtoms, 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

STORAGE AND HANDLING SECTION

Other Information

  • read the directions and warnings before use
  • store at 20º to 25ºC (68º to 77ºF)
  • protect from moisture

INACTIVE INGREDIENT SECTION

carnuba wax, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc, titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments?

Call 1-844-243-1241 or email hi@curistrelief.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

curist

Acid Relief

Famotidine Tablets, 10mg

Acid Reducer

Just One Tablet Prevents & Relieves Heartburn Dut to Acid Indigestion

300 Tablets

famotidinefamotidine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199047famotidine 10 MG Oral TabletPSN2
199047famotidine 10 MG Oral TabletSCD2

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
72559-038-23Famotidine300 mg in 1 BOTTLETABLET3002

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
72559-03872559-038-23

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
A215766-001FAMOTIDINEFAMOTIDINE10MGTABLET / ORAL2021-11-08
A215766-002FAMOTIDINEFAMOTIDINE20MGTABLET / ORAL2021-11-08

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 · 70 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A215766-001FAMOTIDINE10MGTABLET / ORAL2021-11-0884e616aacf4f…
2026-09-14 22:38:342026-08A215766-002FAMOTIDINE20MGTABLET / ORAL2021-11-0884e616aacf4f…
2026-08-18 06:07:402026-07A215766-001FAMOTIDINE10MGTABLET / ORAL2021-11-08caaa826d4ba7…
2026-08-18 06:07:402026-07A215766-002FAMOTIDINE20MGTABLET / ORAL2021-11-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215766-001FAMOTIDINE10MGTABLET / ORAL2021-11-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215766-002FAMOTIDINE20MGTABLET / ORAL2021-11-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215766-001FAMOTIDINE10MGTABLET / ORAL2021-11-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215766-002FAMOTIDINE20MGTABLET / ORAL2021-11-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A215766-001FAMOTIDINE10MGTABLET / ORAL2021-11-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215766-002FAMOTIDINE20MGTABLET / ORAL2021-11-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215766-001FAMOTIDINE10MGTABLET / ORAL2021-11-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215766-002FAMOTIDINE20MGTABLET / ORAL2021-11-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215766-001FAMOTIDINE10MGTABLET / ORAL2021-11-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215766-002FAMOTIDINE20MGTABLET / ORAL2021-11-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215766-001FAMOTIDINE10MGTABLET / ORAL2021-11-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215766-002FAMOTIDINE20MGTABLET / ORAL2021-11-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215766-001FAMOTIDINE10MGTABLET / ORAL2021-11-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215766-002FAMOTIDINE20MGTABLET / ORAL2021-11-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215766-001FAMOTIDINE10MGTABLET / ORAL2021-11-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215766-002FAMOTIDINE20MGTABLET / ORAL2021-11-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215766-001FAMOTIDINE10MGTABLET / ORAL2021-11-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215766-002FAMOTIDINE20MGTABLET / ORAL2021-11-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215766-001FAMOTIDINE10MGTABLET / ORAL2021-11-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A215766-002FAMOTIDINE20MGTABLET / ORAL2021-11-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215766-001FAMOTIDINE10MGTABLET / ORAL2021-11-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215766-002FAMOTIDINE20MGTABLET / ORAL2021-11-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215766-001FAMOTIDINE10MGTABLET / ORAL2021-11-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215766-002FAMOTIDINE20MGTABLET / ORAL2021-11-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215766-001FAMOTIDINE10MGTABLET / ORAL2021-11-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215766-002FAMOTIDINE20MGTABLET / ORAL2021-11-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215766-001FAMOTIDINE10MGTABLET / ORAL2021-11-088072bd15b7f6…
2024-05-31 18:47 UTC2024-05A215766-002FAMOTIDINE20MGTABLET / ORAL2021-11-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215766-001FAMOTIDINE10MGTABLET / ORAL2021-11-085c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215766-002FAMOTIDINE20MGTABLET / ORAL2021-11-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A215766-001FAMOTIDINE10MGTABLET / ORAL2021-11-085d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A215766-002FAMOTIDINE20MGTABLET / ORAL2021-11-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A215766-001FAMOTIDINE10MGTABLET / ORAL2021-11-084b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A215766-002FAMOTIDINE20MGTABLET / ORAL2021-11-084b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A215766-001FAMOTIDINE10MGTABLET / ORAL2021-11-08bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A215766-002FAMOTIDINE20MGTABLET / ORAL2021-11-08bb7c543d1eb4…

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
FamotidineFAMOTIDINELittle Pharma, Inc.33dc93a5-ee03-2e68-e063-6294a90aeee12025-07-05WarningsExact identifier
ndc (package): 72559-038-23
ndc (product): 72559-038
ndc11 (package): 72559003823
spl id: 39334fb3-e395-7819-e063-6294a90a9073
spl set id: 33dc93a5-ee03-2e68-e063-6294a90aeee1

Reported adverse events (FAERS/openFDA)#

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