Welmate Famotidine 10mg

Manufacturer
YYBA Corp
Effective date
2025-07-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:08:50

Label at a glance#

ProductWelmate Famotidine 10mg
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 (of 10 mg) with a glass of water at any time from 15 to 60 minutes before eating food or drinking beverages that cause heartburn to prevent symptoms, swallow 1 tablet (of 20 mg) with a glass of water at any time from 10 to 60 minutes before eating food or drinking b...

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Famotidine, USP 10 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

  • 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

  • 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


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

  • your heartburn continues or worsens
  • you need to take this product for more than 14 days

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. (1-800-222-1222)

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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 (of 10 mg) with a glass of water at any time from 15 to 60 minutes before eating food or drinking beverages that cause heartburn
  • to prevent symptoms, swallow 1 tablet (of 20 mg) with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn
  • 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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Microcrystalline Cellulose, Pre-gelatinized Starch, Sodium Starch Glycolate, Hydroxypropyl Cellulose, Magnesium Stearate, Hypromellose, Titanium Dioxide, Triacetin, Talc, Macrogol

Other information

OTHER SAFETY INFORMATION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-300's Count

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-90's Count

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73581-108-09Welmate Famotidine 10mg90 in 1 BOTTLETABLET902
73581-108-10Welmate Famotidine 10mg300 in 1 BOTTLETABLET3002

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73581-10873581-108-10, 73581-108-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
A215822-001FAMOTIDINEFAMOTIDINE10MGTABLET / ORAL2022-01-28
A215822-002FAMOTIDINEFAMOTIDINE20MGTABLET / ORAL2022-01-28

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 · 68 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-2884e616aacf4f…
2026-09-14 22:38:342026-08A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-2884e616aacf4f…
2026-08-18 06:07:402026-07A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-28caaa826d4ba7…
2026-08-18 06:07:402026-07A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-284b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-28bb7c543d1eb4…

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
Welmate Famotidine 10mgFAMOTIDINE 10MGYYBA Corp1e19d0cc-65d7-8ec4-e063-6394a90a3d2a2025-07-29WarningsExact identifier
ndc (package): 73581-108-10
ndc (package): 73581-108-09
ndc (product): 73581-108
ndc11 (package): 73581010809
ndc11 (package): 73581010810
spl id: 3b0b7c5c-9d4e-5cc4-e063-6294a90acecf
spl set id: 1e19d0cc-65d7-8ec4-e063-6394a90a3d2a

Reported adverse events (FAERS/openFDA)#

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