Kroger Famotidine Tablets USP 10 mg

Manufacturer
KROGER COMPANY | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
Effective date
2024-07-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:14:54

Label at a glance#

ProductOriginal strength heartburn prevention
Active ingredientFAMOTIDINE
Label structure15 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Famotidine USP 10 mg

OTC - PURPOSE SECTION

Purpose

Acid reducer

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings

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 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 Control Center right away. (1-800-222-1222)

DOSAGE & ADMINISTRATION SECTION

Directions

  • 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

OTHER SAFETY INFORMATION

Other 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
  • FDA approved dissolution test specifications differ from USP

INACTIVE INGREDIENT SECTION

Inactive ingredients carnauba wax, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, red iron oxide, talc, titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments?Call 1-800-632-6900

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label-90s-famotidinelabel-90s-famotidineifc-90s-famotidineifc-90s-famotidine719R_Kroger_41226-719_Famotidine Tablets USP 10 mg719R_Kroger_41226-719_Famotidine Tablets USP 10 mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199047famotidine 10 MG Oral TabletPSN3
199047famotidine 10 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
41226-719-06Original strength heartburn prevention10 in 1 BLISTER PACKTABLET103
41226-719-06Original strength heartburn prevention3 in 1 CARTONTABLET33
41226-719-09Original strength heartburn prevention1 in 1 CARTONTABLET13
41226-719-09Original strength heartburn prevention90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41226-719ORIGINAL STRENGTH HEARTBURN PREVENTION (FAMOTIDINE) TABLET [KROGER COMPANY]3Current NDC, 4 package rows20240709_ea1c2838-acbd-18e0-e053-2a95a90a3522.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
41226-71941226-719-06, 41226-719-09

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
A217543-001FAMOTIDINEFAMOTIDINE10MGTABLET / ORAL2023-03-08
A217543-002FAMOTIDINEFAMOTIDINE20MGTABLET / ORAL2023-03-08

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 · 50 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A217543-001FAMOTIDINE10MGTABLET / ORAL2023-03-0884e616aacf4f…
2026-09-14 22:38:342026-08A217543-002FAMOTIDINE20MGTABLET / ORAL2023-03-0884e616aacf4f…
2026-08-18 06:07:402026-07A217543-001FAMOTIDINE10MGTABLET / ORAL2023-03-08caaa826d4ba7…
2026-08-18 06:07:402026-07A217543-002FAMOTIDINE20MGTABLET / ORAL2023-03-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217543-001FAMOTIDINE10MGTABLET / ORAL2023-03-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217543-002FAMOTIDINE20MGTABLET / ORAL2023-03-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217543-001FAMOTIDINE10MGTABLET / ORAL2023-03-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217543-002FAMOTIDINE20MGTABLET / ORAL2023-03-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A217543-001FAMOTIDINE10MGTABLET / ORAL2023-03-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217543-002FAMOTIDINE20MGTABLET / ORAL2023-03-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217543-001FAMOTIDINE10MGTABLET / ORAL2023-03-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217543-002FAMOTIDINE20MGTABLET / ORAL2023-03-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217543-001FAMOTIDINE10MGTABLET / ORAL2023-03-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217543-002FAMOTIDINE20MGTABLET / ORAL2023-03-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217543-001FAMOTIDINE10MGTABLET / ORAL2023-03-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217543-002FAMOTIDINE20MGTABLET / ORAL2023-03-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217543-001FAMOTIDINE10MGTABLET / ORAL2023-03-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217543-002FAMOTIDINE20MGTABLET / ORAL2023-03-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217543-001FAMOTIDINE10MGTABLET / ORAL2023-03-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217543-002FAMOTIDINE20MGTABLET / ORAL2023-03-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217543-001FAMOTIDINE10MGTABLET / ORAL2023-03-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217543-002FAMOTIDINE20MGTABLET / ORAL2023-03-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217543-001FAMOTIDINE10MGTABLET / ORAL2023-03-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A217543-002FAMOTIDINE20MGTABLET / ORAL2023-03-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217543-001FAMOTIDINE10MGTABLET / ORAL2023-03-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217543-002FAMOTIDINE20MGTABLET / ORAL2023-03-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217543-001FAMOTIDINE10MGTABLET / ORAL2023-03-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217543-002FAMOTIDINE20MGTABLET / ORAL2023-03-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217543-001FAMOTIDINE10MGTABLET / ORAL2023-03-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217543-002FAMOTIDINE20MGTABLET / ORAL2023-03-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217543-001FAMOTIDINE10MGTABLET / ORAL2023-03-088072bd15b7f6…
2024-05-31 18:47 UTC2024-05A217543-002FAMOTIDINE20MGTABLET / ORAL2023-03-088072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217543-001FAMOTIDINE10MGTABLET / ORAL2023-03-086a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217543-002FAMOTIDINE20MGTABLET / ORAL2023-03-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A217543-001FAMOTIDINE10MGTABLET / ORAL2023-03-081c564ffb4f44…
2024-02-18 07:12 UTC2024-02A217543-002FAMOTIDINE20MGTABLET / ORAL2023-03-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A217543-001FAMOTIDINE10MGTABLET / ORAL2023-03-08ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A217543-002FAMOTIDINE20MGTABLET / ORAL2023-03-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217543-001FAMOTIDINE10MGTABLET / ORAL2023-03-08a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217543-002FAMOTIDINE20MGTABLET / ORAL2023-03-08a72a2bbeb626…

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
Original strength heartburn preventionFAMOTIDINEKROGER COMPANYea1c2838-acbd-18e0-e053-2a95a90a35222024-07-08WarningsExact identifier
ndc (package): 41226-719-06
ndc (package): 41226-719-09
ndc (product): 41226-719
ndc11 (package): 41226071909
ndc11 (package): 41226071906
spl id: 1cb86ee4-41c1-1196-e063-6394a90a9199
spl set id: ea1c2838-acbd-18e0-e053-2a95a90a3522

Reported adverse events (FAERS/openFDA)#

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