Heartburn Relief

Manufacturer
Shield Pharmaceuticals Corp
Effective date
2025-10-31
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:41:44

Label at a glance#

ProductHeartburn Relief
Active ingredientFAMOTIDINE
Label structure17 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

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)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each liquid-filled capsule)

OTC - ACTIVE INGREDIENT SECTION

Famotidine 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

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 aretaking

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.

Directions

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

adults and children 12 years and over:

  • to relievesymptoms, swallow 1 tablet with a glass of water. Do not chew.
  • to preventsymptoms, swallow 1 tablet with a glass of water at any time from 15 to 60 minutes beforeeating 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

OTHER SAFETY INFORMATION

  • 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

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

Questions or comments?

OTC - QUESTIONS SECTION

1-800-373-6981 (toll-free)

SPL UNCLASSIFIED SECTION

Distributed by:
Shield Pharmaceuticals Corp.
Hauppauge, NY 11788

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Heartburn Relief


Famotidine Tablets USP 10 mg
Acid Reducer


Just One Tablet!
Prevents and Relieves Heartburn Due to Acid Indigestion

Famotidine 10 mg 50 ct CartonFamotidine 10 mg 50 ct Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199047famotidine 10 MG Oral TabletPSN4
199047famotidine 10 MG Oral TabletSCD4

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codewww.shieldpharmacorp.com/Famotidine 10 mg 50 ct Carton.jpg

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
83059-0031-5Heartburn Relief50 in 1 BOTTLETABLET, FILM COATED504
83059-0031-5Heartburn Relief1 in 1 PACKAGETABLET, FILM COATED14

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83059-003183059-0031-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32024-12-26full-release2026-06-01 00:49:13

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
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 · 72 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A215766-001FAMOTIDINE10MGTABLET / ORAL2021-11-08c2088c7a36db…
2026-10-15 13:18:302026-09A215766-002FAMOTIDINE20MGTABLET / ORAL2021-11-08c2088c7a36db…
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…

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
Heartburn ReliefFAMOTIDINEShield Pharmaceuticals Corpa12ec91d-244f-45c5-8590-d1e4485fe3612025-10-31WarningsExact identifier
ndc (package): 83059-0031-5
ndc (product): 83059-0031
ndc11 (package): 83059003105
spl id: 4276c109-6851-5045-e063-6294a90a592e
spl set id: a12ec91d-244f-45c5-8590-d1e4485fe361

Reported adverse events (FAERS/openFDA)#

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