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#
Contacts and useful links#
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
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| FAMOTIDINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 396bde5c-c78e-2f8b-ab1f-2ee6ba32bcae | Product name | 7 | 20260317 |
| 1e73f975-1ce7-705e-2bcf-788b1b5e24ba | Product name | 5 | 20251124 |
| cf645750-2e70-f6e1-c05a-a52847def5dd | Product name | 9 | 20250312 |
| 4fdc761c-585e-054b-8ebe-86130a26e4c1 | Product name | 2 | 20221205 |
| fc2e1e31-353a-2c24-a4b4-fcf93bf7e38e | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 41226-719-06 | Original strength heartburn prevention | 10 in 1 BLISTER PACK | TABLET | 10 | 3 | |
| 41226-719-06 | Original strength heartburn prevention | 3 in 1 CARTON | TABLET | 3 | 3 | |
| 41226-719-09 | Original strength heartburn prevention | 1 in 1 CARTON | TABLET | 1 | 3 | |
| 41226-719-09 | Original strength heartburn prevention | 90 in 1 BOTTLE | TABLET | 90 | 3 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Original strength heartburn prevention
- Famotidine
- FERRIC OXIDE RED
- TALC
- SILICON DIOXIDE
- HYDROXYPROPYL CELLULOSE, UNSPECIFIED
- CARNAUBA WAX
- HYPROMELLOSES
- MAGNESIUM STEARATE
- TITANIUM DIOXIDE
- CELLULOSE, MICROCRYSTALLINE
- STARCH, CORN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 41226-719 | 41226-719-06, 41226-719-09 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FERRIC OXIDE RED | 1K09F3G675 | IACT |
| TALC | 7SEV7J4R1U | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| HYDROXYPROPYL CELLULOSE, UNSPECIFIED | 9XZ8H6N6OH | IACT |
| FAMOTIDINE | 5QZO15J2Z8 | ACTIB |
| CARNAUBA WAX | R12CBM0EIZ | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A217543-001 | FAMOTIDINE | FAMOTIDINE | 10MG | TABLET / ORAL | 2023-03-08 | ||
| A217543-002 | FAMOTIDINE | FAMOTIDINE | 20MG | TABLET / ORAL | 2023-03-08 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A217543-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2023-03-08 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A217543-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2023-03-08 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A217543-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2023-03-08 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A217543-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2023-03-08 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A217543-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2023-03-08 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A217543-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2023-03-08 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217543-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2023-03-08 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217543-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2023-03-08 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A217543-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2023-03-08 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A217543-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2023-03-08 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217543-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2023-03-08 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217543-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2023-03-08 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217543-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2023-03-08 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217543-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2023-03-08 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217543-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2023-03-08 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217543-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2023-03-08 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217543-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2023-03-08 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217543-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2023-03-08 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217543-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2023-03-08 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217543-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2023-03-08 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217543-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2023-03-08 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217543-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2023-03-08 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A217543-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2023-03-08 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A217543-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2023-03-08 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217543-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2023-03-08 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217543-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2023-03-08 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217543-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2023-03-08 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217543-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2023-03-08 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217543-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2023-03-08 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217543-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2023-03-08 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A217543-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2023-03-08 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A217543-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2023-03-08 | 8072bd15b7f6… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A217543-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2023-03-08 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A217543-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2023-03-08 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A217543-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2023-03-08 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A217543-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2023-03-08 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A217543-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2023-03-08 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A217543-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2023-03-08 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A217543-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2023-03-08 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A217543-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2023-03-08 | a72a2bbeb626… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Original strength heartburn prevention | FAMOTIDINE | KROGER COMPANY | ea1c2838-acbd-18e0-e053-2a95a90a3522 | 2024-07-08 | Warnings | 41226-719-06 41226-719-09 41226-719 41226071909 41226071906 1cb86ee4-41c1-1196-e063-6394a90a9199 ea1c2838-acbd-18e0-e053-2a95a90a3522 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.


