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
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
For 10 mg: • adults and children 12 years and over: o to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. o 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 o do not use more than 2 tablets in 24 hours • children under 12 years: ask a doctor For 20 mg: • adults and children 12 years and ...
For 10 mg:
Famotidine USP 10 mg
For 20 mg:
Famotidine USP 20 mg
Acid Reducer
Allergy alert: Do not use if you are allergic to famotidine or other acid reducers
• 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
• 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
taking a prescription drug. Acid reducers may interact with certain prescription drugs.
• your heartburn continues or worsens
• you need to take this product for more than 14 days
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
For 10mg:
• adults and children 12 years and over:
o to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
o 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
o do not use more than 2 tablets in 24 hours
• children under 12 years: ask a doctor
For 20 mg:
• adults and children 12 years and over:
o to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
o to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn
o do not use more than 2 tablets in 24 hours
• children under 12 years: ask a doctor
• 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
•Meets USP dissolution test 2
For 10 mg:
carnauba wax, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, red iron oxide, talc, titanium dioxide
For 20 mg:
carnauba wax, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc, titanium dioxide
Call 1-877-376-4271 (weekdays 9 AM to 5 PM)
Tips for Managing Heartburn
• Do not lie flat or bend over after eating
• Do not wear tight-fitting clothing around the stomach
• 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
• Eat slowly and avoid big meals
• If overweight, lose weight
• Quit smoking
Manufactured for:
Time-Cap Labs, Inc.
7 Michael Avenue,
Farmingdale,
NY 11735, USA
Manufactured by:
Marksans Pharma Ltd.
Plot No. L-82, L-83
Verna Indl. Estate
Verna, Goa-403722, India
Famotidine Tablets USP, 10 mg
NDC: 25000-086-36
Famotidine Tablets USP 10 mg
30's (3 x 10's blister) count Carton Label
NDC: 25000-086-03
Famotidine Tablets USP 10 mg
30's count Bottle Label
NDC: 25000-086-03
Famotidine Tablets USP 10 mg
30's count Carton Label
NDC: 25000-086-08
Famotidine Tablets USP 10 mg
100's count Bottle Label
NDC: 25000-086-08
Famotidine Tablets USP 10 mg
100's count Carton Label
Famotidine Tablets USP, 20 mg
NDC: 25000-087-36
Famotidine Tablets USP 20 mg
30's (3 x 10's blister) count Carton Label
NDC: 25000-087-03
Famotidine Tablets USP 20 mg
30's count Bottle Label
NDC: 25000-087-03
Famotidine Tablets USP 20 mg
30's count Carton Label
NDC: 25000-087-08
Famotidine Tablets USP 20 mg
100's count Bottle Label
NDC: 25000-087-08
Famotidine Tablets USP 20 mg
100's count Carton Label
NDC: 25000-087-82
Famotidine Tablets USP 20 mg
200's count Carton Label
NDC: 25000-087-82
Famotidine Tablets USP 20 mg
200's count Bottle Label
| Class | Version | Type | Effective |
|---|---|---|---|
| FAMOTIDINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| 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 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 25000-086-03 | Famotidine 10 mg | 30 in 1 BOTTLE | TABLET, COATED | 30 | 5 | |
| 25000-086-03 | Famotidine 10 mg | 1 in 1 CARTON | TABLET, COATED | 1 | 5 | |
| 25000-086-07 | Famotidine 10 mg | 90 in 1 BOTTLE | TABLET, COATED | 90 | 5 | |
| 25000-086-07 | Famotidine 10 mg | 1 in 1 CARTON | TABLET, COATED | 1 | 5 | |
| 25000-086-08 | Famotidine 10 mg | 100 in 1 BOTTLE | TABLET, COATED | 100 | 5 | |
| 25000-086-08 | Famotidine 10 mg | 1 in 1 CARTON | TABLET, COATED | 1 | 5 | |
| 25000-086-36 | Famotidine 10 mg | 10 in 1 BLISTER PACK | TABLET, COATED | 10 | 5 | |
| 25000-086-36 | Famotidine 10 mg | 3 in 1 CARTON | TABLET, COATED | 3 | 5 | |
| 25000-087-03 | Famotidine 20 mg | 30 in 1 BOTTLE | TABLET, COATED | 30 | 5 | |
| 25000-087-03 | Famotidine 20 mg | 1 in 1 CARTON | TABLET, COATED | 1 | 5 | |
| 25000-087-05 | Famotidine 20 mg | 50 in 1 BOTTLE | TABLET, COATED | 50 | 5 | |
| 25000-087-05 | Famotidine 20 mg | 1 in 1 CARTON | TABLET, COATED | 1 | 5 | |
| 25000-087-08 | Famotidine 20 mg | 1 in 1 CARTON | TABLET, COATED | 1 | 5 | |
| 25000-087-08 | Famotidine 20 mg | 100 in 1 BOTTLE | TABLET, COATED | 100 | 5 | |
| 25000-087-36 | Famotidine 20 mg | 3 in 1 CARTON | TABLET, COATED | 3 | 5 | |
| 25000-087-36 | Famotidine 20 mg | 10 in 1 BLISTER PACK | TABLET, COATED | 10 | 5 | |
| 25000-087-82 | Famotidine 20 mg | 1 in 1 CARTON | TABLET, COATED | 1 | 5 | |
| 25000-087-82 | Famotidine 20 mg | 200 in 1 BOTTLE | TABLET, COATED | 200 | 5 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 25000-086 | FAMOTIDINE 10 MG TABLET, COATED FAMOTIDINE 20 MG TABLET, COATED [MARKSANS PHARMA LIMITED] | 5 | Current NDC, 8 package rows | 20250325_58b653eb-6539-4b79-9d22-df6eaf35307f.zip |
| 25000-087 | FAMOTIDINE 10 MG TABLET, COATED FAMOTIDINE 20 MG TABLET, COATED [MARKSANS PHARMA LIMITED] | 5 | Current NDC, 10 package rows | 20250325_58b653eb-6539-4b79-9d22-df6eaf35307f.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 25000-086 | 25000-086-36, 25000-086-03, 25000-086-08, 25000-086-07 |
| 25000-087 | 25000-087-36, 25000-087-03, 25000-087-08, 25000-087-05, 25000-087-82 |
Every source-derived ingredient row is available through these pages.
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| 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 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 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 |
|---|---|---|---|---|---|---|
| Famotidine 10 mg | FAMOTIDINE 10 MG | MARKSANS PHARMA LIMITED | 58b653eb-6539-4b79-9d22-df6eaf35307f | 2024-09-30 | Warnings | 25000-086-03 25000-087-82 25000-086-07 25000-087-05 25000-086-36 25000-086-08 25000-087-36 25000-087-08 25000-087-03 25000-086 25000-087 25000008736 25000008603 25000008708 25000008608 25000008705 25000008703 25000008607 25000008782 25000008636 c1fe0ae2-1d7b-409d-97cb-9e03eeb7f402 58b653eb-6539-4b79-9d22-df6eaf35307f |
Adverse event summaries are temporarily unavailable. Other product information remains available.