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
● 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 10 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
Famotidine USP 20 mg
Acid reducer
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.
● if you have kidney disease, except under the advice and supervision of a 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
Stop use and ask a doctor if
● your heartburn continues or worsens
● you need to take this product for more than 14 days
PREGNANCY OR BREAST FEEDING
If pregnant or breast-feeding, ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away.
● 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 10 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
● read the directions and warnings before use
● store at 20°-25°C (68°-77°F)
● keep the carton. It contains important information.
● protect from moisture
Hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, magnesium stearate, polyethylene glycol, pregelatinized starch, talc and titanium dioxide.
Call 1-800-346-6854
Manufactured by:
Wockhardt Limited,
Mumbai, India.
Distributed by:
Wockhardt USA LLC.
20 Waterview Blvd.
Parsippany, NJ 07054
USA.
Iss.130810
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| FAMOTIDINE | ACTIVE INGREDIENT | 5QZO15J2Z8 | 2 | |
| FAMOTIDINE | ACTIVE MOIETY | 5QZO15J2Z8 | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 2 | |
| HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED | INACTIVE INGREDIENT | 2165RE0K14 | 2 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 2 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 64679-374 | 64679-374-01, 64679-374-08, 64679-374-05, 64679-374-07, 64679-374-00, 64679-374-09 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FAMOTIDINE | 5QZO15J2Z8 | ACTIB |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED | 2165RE0K14 | IACT |
| HYPROMELLOSE 2910 (6 MPA.S) | 0WZ8WG20P6 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| TALC | 7SEV7J4R1U | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| TALC | TALC | 7SEV7J4R1U | TABLET / SUBLINGUAL | 32.4 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, DELAYED RELEASE / ORAL | 349 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | INSERT / VAGINAL | 147 mg | ||
| HYPROMELLOSE 2910 (6 MPA.S) | HYPROMELLOSE 2910 (6 MPA.S) | 0WZ8WG20P6 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 174 mg | ||
| HYPROMELLOSE 2910 (6 MPA.S) | HYPROMELLOSE 2910 (6 MPA.S) | 0WZ8WG20P6 | TABLET, EXTENDED RELEASE / ORAL | 85 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | DROPS / ORAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | LOZENGE / ORAL | 420 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, COATED / ORAL | 256 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, DELAYED RELEASE / ORAL | 420 mg | ||
| TALC | TALC | 7SEV7J4R1U | LOZENGE / ORAL | 50 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / SUBLINGUAL | 17.5 mg | ||
| TALC | TALC | 7SEV7J4R1U | GRANULE / ORAL | 322 mg | ||
| HYPROMELLOSE 2910 (6 MPA.S) | HYPROMELLOSE 2910 (6 MPA.S) | 0WZ8WG20P6 | TABLET, ORALLY DISINTEGRATING / ORAL | 39 mg | ||
| HYPROMELLOSE 2910 (6 MPA.S) | HYPROMELLOSE 2910 (6 MPA.S) | 0WZ8WG20P6 | CAPSULE / ORAL | 600 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CREAM / TOPICAL | 10 %w/w | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE PARTICLES / ORAL | 580 mg | ||
| TALC | TALC | 7SEV7J4R1U | POWDER / TOPICAL | 9235 mg | ||
| HYPROMELLOSE 2910 (6 MPA.S) | HYPROMELLOSE 2910 (6 MPA.S) | 0WZ8WG20P6 | TABLET, DELAYED RELEASE / ORAL | 77 mg | ||
| TALC | TALC | 7SEV7J4R1U | OINTMENT / TOPICAL | 74.6 %w/w | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | GEL / VAGINAL | 1250 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / TOPICAL | 104 mg | ||
| HYPROMELLOSE 2910 (6 MPA.S) | HYPROMELLOSE 2910 (6 MPA.S) | 0WZ8WG20P6 | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 261 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, EXTENDED RELEASE / ORAL | 90 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 615 mg | ||
| HYPROMELLOSE 2910 (6 MPA.S) | HYPROMELLOSE 2910 (6 MPA.S) | 0WZ8WG20P6 | TABLET / ORAL | 880 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / ORAL | 72 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CREAM / TOPICAL | NA | ||
| TALC | TALC | 7SEV7J4R1U | GUM, CHEWING / BUCCAL | NA | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CONCENTRATE / ORAL | 3000 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / ORAL | 1000 mg | ||
| HYPROMELLOSE 2910 (6 MPA.S) | HYPROMELLOSE 2910 (6 MPA.S) | 0WZ8WG20P6 | GRANULE, FOR SUSPENSION / ORAL | 42 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING / ORAL | 6 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, EXTENDED RELEASE / ORAL | 67 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | SUSPENSION / ORAL | 1600 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | WAFER / ORAL | 66 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, ORALLY DISINTEGRATING / ORAL | 2 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, SUGAR COATED / ORAL | NA | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CAPSULE / ORAL | 13440 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, COATED / ORAL | 87 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GRANULE, FOR SUSPENSION / ORAL | 143 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, DELAYED RELEASE / ORAL | 35 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, DELAYED RELEASE / ORAL | 366 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / BUCCAL | 17.5 mg | ||
| HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED | LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE | 2165RE0K14 | CAPSULE / ORAL | 150 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, FILM COATED / ORAL | 91 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 357 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CAPSULE, EXTENDED RELEASE / ORAL | 17 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SWAB / TOPICAL | 5250 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, EXTENDED RELEASE / ORAL | 1246 mg | ||
| HYPROMELLOSE 2910 (6 MPA.S) | HYPROMELLOSE 2910 (6 MPA.S) | 0WZ8WG20P6 | TABLET, COATED / ORAL | 12 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, ORALLY DISINTEGRATING / ORAL | 1800 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SOLUTION / OPHTHALMIC | 46 mg | ||
| TALC | TALC | 7SEV7J4R1U | GRANULE, FOR SUSPENSION / ORAL | 296 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, CHEWABLE / ORAL | 1725 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, COATED PELLETS / ORAL | 456 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CREAM / TOPICAL | 80 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE, DENTIFRICE / DENTAL | 0.4 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | INSERT, EXTENDED RELEASE / OPHTHALMIC | 0.4 mg |
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 |
|---|---|---|---|---|---|---|---|
| A090837-001 | FAMOTIDINE | FAMOTIDINE | 20MG | TABLET / ORAL | 2010-08-04 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A090837-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2010-08-04 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A090837-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2010-08-04 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090837-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2010-08-04 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090837-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2010-08-04 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090837-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2010-08-04 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090837-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2010-08-04 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090837-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2010-08-04 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090837-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2010-08-04 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090837-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2010-08-04 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090837-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2010-08-04 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090837-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2010-08-04 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090837-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2010-08-04 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090837-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2010-08-04 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090837-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2010-08-04 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090837-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2010-08-04 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090837-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2010-08-04 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A090837-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2010-08-04 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090837-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2010-08-04 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A090837-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2010-08-04 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A090837-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2010-08-04 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A090837-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2010-08-04 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A090837-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2010-08-04 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A090837-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2010-08-04 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090837-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2010-08-04 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A090837-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2010-08-04 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A090837-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2010-08-04 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A090837-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2010-08-04 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A090837-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2010-08-04 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A090837-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2010-08-04 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A090837-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2010-08-04 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090837-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2010-08-04 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A090837-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2010-08-04 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A090837-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2010-08-04 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090837-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2010-08-04 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090837-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2010-08-04 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090837-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2010-08-04 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090837-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2010-08-04 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A090837-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2010-08-04 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A090837-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2010-08-04 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090837-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2010-08-04 | 3a93d1ddd44b… |
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 |
|---|---|---|---|---|---|---|
| 26d964f1-b9a8-8ecb-e063-6394a90ad73f | dd45b1fe-76f1-4486-9ec9-ad409208afb4 | 2024-11-14 | Warnings | dd45b1fe-76f1-4486-9ec9-ad409208afb4 |
Adverse event summaries are temporarily unavailable. Other product information remains available.