Clemastine is a prescription medicine indicated for the relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhea, pruritus, and lacrimation, among other approved uses. It is available as syrup and tablets for oral use. MedsAcross supplies Clemastine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
Clemastine Fumarate Tablets USP, 2.68 mg are indicated for the relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhea, pruritus, and lacrimation. Clemastine Fumarate Tablets USP, 2.68 mg are also indicated for the relief of mild, uncomplicated allergic skin manifestations of urticaria and angioedema. It should be noted that clemastine fumarate is indicated for the dermatologic indications at the 2.68 mg dosage level only.
Source: US FDA prescribing information
DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND RESPONSE OF THE PATIENT. Clemastine Fumarate Tablets 2.68 mg The maximum recommended dosage is one tablet three times daily. Many patients respond favorably to a single dose which may be repeated as required, but not to exceed three tablets daily.
Source: US FDA prescribing information
Usage in Nursing Mothers Because of the higher risk of antihistamines for infants generally and for newborns and prematures in particular, antihistamine therapy is contraindicated in nursing mothers. Usage in Lower Respiratory Disease Antihistamines should not be used to treat lower respiratory tract symptoms including asthma. Antihistamines are also contraindicated in the following conditions: Hypersensitivity to clemastine fumarate or other antihistamines of similar chemical structure. Monoamine oxidase inhibitor therapy.
Source: US FDA prescribing information
Antihistamines should be used with considerable caution in patients with: narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, and bladder neck obstruction. Usage in Children Safety and efficacy of clemastine fumarate have not been established in children under the age of 12 years. Usage in Pregnancy Experience with this drug in pregnant women is inadequate to determine whether there is exists a potential for harm to the developing fetus. Usage with CNS Depressants Clemastine has additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, etc.).
Source: US FDA prescribing information
Transient drowsiness, the most common adverse reaction associated with clemastine fumarate, occurs relatively frequently and may require discontinuation of therapy in some instances. Antihistaminic Compounds It should be noted that the following reactions have occurred with one or more antihistamines and, therefore, should be kept in mind when prescribing drugs belonging to this class, including clemastine. The most frequent adverse reactions are italicized. General: Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of the mouth, nose, and throat. Cardiovascular System: Hypotension, headache, palpitations, tachycardia, extrasystoles. Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis.
Source: US FDA prescribing information
MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines.
Source: US FDA prescribing information
Store at 20° to 25°C (68° to 77°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
3 presentations of Clemastine, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Clemastine 0.67 mg/5 mL syrupOralGeneric name | — | US FDA | Available on request |
| Clemastine 2.68 mg tabletOralGeneric name | — | US FDA | Available on request |
| Clemsza 2.68 mg tabletOral | IPG Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 25 February 1977 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Clemastine in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 3 presentations of Clemastine and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Clemastine, including Clemsza.
Yes. The US FDA first approved Clemastine on 25 February 1977, according to Drugs@FDA.
No listed presentation of Clemastine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Clemastine is classified under ATC code D04AA14 (Clemastine).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.