Indications and uses
temporarily reduces these symptoms of the common cold, hay fever, and other respiratory allergies: • runny nose • itchy, watery eyes • sneezing • itching of the nose or throat
temporarily reduces these symptoms of the common cold, hay fever, and other respiratory allergies: • runny nose • itchy, watery eyes • sneezing • itching of the nose or throat
• adults and children 12 years of age and over: take 1 tablet every 12 hours; not more than 2 tablets in 24 hours unless directed by a doctor • children under 12 years of age: consult a doctor
• sodium free • store at 15°-30°C (59°-86°F)
Clemastine fumarate, USP 1.34 mg (equivalent to 1 mg clemastine)
Antihistamine
temporarily reduces these symptoms of the common cold, hay fever, and other respiratory allergies:
taking sedatives or tranquilizers
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away.
colloidal silicon dioxide, corn starch, lactose monohydrate, povidone, pregelatinized starch, stearic acid
1-800-719-9260
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 24385-183-51 | EA - Each | 24385-183 | 9657ef5a-13a8-49ac-ad14-3f166ff6e646 | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| CLEMASTINE FUMARATE | ACTIVE INGREDIENT | 19259EGQ3D | 2 | |
| CLEMASTINE | ACTIVE MOIETY | 95QN29S1ID | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | 2 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 2 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 24385-183 | 24385-183-51 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CLEMASTINE FUMARATE | 19259EGQ3D | ACTIB |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| POVIDONE, UNSPECIFIED | FZ989GH94E | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| STARCH, CORN | O8232NY3SJ | 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 |
|---|---|---|---|---|---|---|
| POVIDONE | POVIDONE | FZ989GH94E | CAPSULE, EXTENDED RELEASE / ORAL | 56 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, FOR SUSPENSION / ORAL | 2794 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, DELAYED RELEASE / ORAL | 713 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, CHEWABLE / ORAL | 1412 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | IMPLANT / SUBCUTANEOUS | 1.04 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, EXTENDED RELEASE / ORAL | 2575 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 520 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET / ORAL | 216 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | GRANULE, FOR SUSPENSION / ORAL | NA | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION / ORAL | 900 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION / INTRAVENOUS | 900 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE PARTICLES / ORAL | 170 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS | 174 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, DELAYED RELEASE / ORAL | 40 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING / ORAL | 100 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | CAPSULE, DELAYED RELEASE / ORAL | 2087 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, EXTENDED RELEASE / TRANSDERMAL | 49 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, EXTENDED RELEASE / ORAL | 168 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | PASTILLE / ORAL | NA | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, COATED / ORAL | 49.2 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | CAPSULE, COATED / ORAL | 300 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE, EXTENDED RELEASE / ORAL | 194 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 32 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, ORALLY DISINTEGRATING / ORAL | 10 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | SOLUTION / OPHTHALMIC | 1.8 %w/v | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CREAM / VAGINAL | 1088 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE / ORAL | 5000 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | POWDER, FOR SUSPENSION / ORAL | 34 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | OINTMENT / TOPICAL | 15 %w/w | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, FOR SUSPENSION / ORAL | 2 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY | 47.5 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, ORALLY DISINTEGRATING / ORAL | 366 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CONCENTRATE / ORAL | NA | ||
| POVIDONE | POVIDONE | FZ989GH94E | CAPSULE, COATED PELLETS / ORAL | 10.03 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SOLUTION / ORAL | 1.8 mg/120ml | ||
| POVIDONE | POVIDONE | FZ989GH94E | SYSTEM / TOPICAL | 41 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | SUSPENSION/ DROPS / OPHTHALMIC | 0.6 %w/v | ||
| POVIDONE | POVIDONE | FZ989GH94E | IMPLANT / SUBCUTANEOUS | 6 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 69 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS | 214 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / BUCCAL | 3 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | GRANULE, FOR SOLUTION / ORAL | 1691.8 mg/120ml | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 750 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / SUBLINGUAL | 9 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, COATED / ORAL | 1301 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | CREAM / VAGINAL | 586 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SOLUTION / ORAL | 280 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION / ORAL | 200 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | EMULSION / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, COATED / ORAL | 176 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE / ORAL | 1190 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / NASAL | 20 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SHAMPOO / TOPICAL | 9.7 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | PASTE / DENTAL | 34 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / VAGINAL | 8 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / TOPICAL | 6 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CREAM / VAGINAL | 51 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / ORAL | 336 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA |
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 |
|---|---|---|---|---|---|---|---|
| A074512-001 | CLEMASTINE FUMARATE | CLEMASTINE FUMARATE | 1.34MG | TABLET / ORAL | 1995-11-22 |
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 | A074512-001 | CLEMASTINE FUMARATE | 1.34MG | TABLET / ORAL | 1995-11-22 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A074512-001 | CLEMASTINE FUMARATE | 1.34MG | TABLET / ORAL | 1995-11-22 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A074512-001 | CLEMASTINE FUMARATE | 1.34MG | TABLET / ORAL | 1995-11-22 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074512-001 | CLEMASTINE FUMARATE | 1.34MG | TABLET / ORAL | 1995-11-22 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A074512-001 | CLEMASTINE FUMARATE | 1.34MG | TABLET / ORAL | 1995-11-22 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074512-001 | CLEMASTINE FUMARATE | 1.34MG | TABLET / ORAL | 1995-11-22 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074512-001 | CLEMASTINE FUMARATE | 1.34MG | TABLET / ORAL | 1995-11-22 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074512-001 | CLEMASTINE FUMARATE | 1.34MG | TABLET / ORAL | 1995-11-22 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074512-001 | CLEMASTINE FUMARATE | 1.34MG | TABLET / ORAL | 1995-11-22 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074512-001 | CLEMASTINE FUMARATE | 1.34MG | TABLET / ORAL | 1995-11-22 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074512-001 | CLEMASTINE FUMARATE | 1.34MG | TABLET / ORAL | 1995-11-22 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074512-001 | CLEMASTINE FUMARATE | 1.34MG | TABLET / ORAL | 1995-11-22 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074512-001 | CLEMASTINE FUMARATE | 1.34MG | TABLET / ORAL | 1995-11-22 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074512-001 | CLEMASTINE FUMARATE | 1.34MG | TABLET / ORAL | 1995-11-22 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074512-001 | CLEMASTINE FUMARATE | 1.34MG | TABLET / ORAL | 1995-11-22 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A074512-001 | CLEMASTINE FUMARATE | 1.34MG | TABLET / ORAL | 1995-11-22 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074512-001 | CLEMASTINE FUMARATE | 1.34MG | TABLET / ORAL | RS | 1995-11-22 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A074512-001 | CLEMASTINE FUMARATE | 1.34MG | TABLET / ORAL | RS | 1995-11-22 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A074512-001 | CLEMASTINE FUMARATE | 1.34MG | TABLET / ORAL | RS | 1995-11-22 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A074512-001 | CLEMASTINE FUMARATE | 1.34MG | TABLET / ORAL | RS | 1995-11-22 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A074512-001 | CLEMASTINE FUMARATE | 1.34MG | TABLET / ORAL | RS | 1995-11-22 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A074512-001 | CLEMASTINE FUMARATE | 1.34MG | TABLET / ORAL | RS | 1995-11-22 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A074512-001 | CLEMASTINE FUMARATE | 1.34MG | TABLET / ORAL | RS | 1995-11-22 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A074512-001 | CLEMASTINE FUMARATE | 1.34MG | TABLET / ORAL | RS | 1995-11-22 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A074512-001 | CLEMASTINE FUMARATE | 1.34MG | TABLET / ORAL | RS | 1995-11-22 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A074512-001 | CLEMASTINE FUMARATE | 1.34MG | TABLET / ORAL | RS | 1995-11-22 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A074512-001 | CLEMASTINE FUMARATE | 1.34MG | TABLET / ORAL | RS | 1995-11-22 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A074512-001 | CLEMASTINE FUMARATE | 1.34MG | TABLET / ORAL | RS | 1995-11-22 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A074512-001 | CLEMASTINE FUMARATE | 1.34MG | TABLET / ORAL | RS | 1995-11-22 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A074512-001 | CLEMASTINE FUMARATE | 1.34MG | TABLET / ORAL | 1995-11-22 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A074512-001 | CLEMASTINE FUMARATE | 1.34MG | TABLET / ORAL | 1995-11-22 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A074512-001 | CLEMASTINE FUMARATE | 1.34MG | TABLET / ORAL | 1995-11-22 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A074512-001 | CLEMASTINE FUMARATE | 1.34MG | TABLET / ORAL | 1995-11-22 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A074512-001 | CLEMASTINE FUMARATE | 1.34MG | TABLET / ORAL | 1995-11-22 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A074512-001 | CLEMASTINE FUMARATE | 1.34MG | TABLET / ORAL | 1995-11-22 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A074512-001 | CLEMASTINE FUMARATE | 1.34MG | TABLET / ORAL | 1995-11-22 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A074512-001 | CLEMASTINE FUMARATE | 1.34MG | TABLET / ORAL | 1995-11-22 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A074512-001 | CLEMASTINE FUMARATE | 1.34MG | TABLET / ORAL | 1995-11-22 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A074512-001 | CLEMASTINE FUMARATE | 1.34MG | TABLET / ORAL | 1995-11-22 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A074512-001 | CLEMASTINE FUMARATE | 1.34MG | TABLET / ORAL | 1995-11-22 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| 8a06e6a0-cbec-4335-b02e-05ccdccdc1fa | 76bcabd8-5bce-4f14-9b8e-3aadabbbc7a4 | 2020-11-02 | Warnings | 76bcabd8-5bce-4f14-9b8e-3aadabbbc7a4 |
Adverse event summaries are temporarily unavailable. Other product information remains available.