Clemsza
2.68 mg · Tablet
- Prescription only
- Active substance
- Clemastine Fumarate
- Made by
- IPG Pharmaceuticals, Inc.
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
At a glance
Quoted from the official label · 2025-07-30
- 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 2.68 mg The maximum recommended dosage is one tablet three times daily.
Full directions ↓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.
All warnings ↓- Prescription only
- FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
- 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.
From the official label · 2025-07-30 · DailyMed
How it works
From this product’s own US prescribing label.
Clemastine fumarate is an antihistamine with anticholinergic (drying) and sedative side effects.
Antihistamines appear to compete with histamine for cell receptor sites on effector cells.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-07-30
Do not take it if
- 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 (see Drug Interactions section).
Quoted from the official label, section “Contraindications”.
How to take it
These directions are for this exact strength and form. Another one is different.
- 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.
Quoted from the official label, section “Dosage & Administration”.
Other warnings
- 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.).
- Usage in Activities Requiring Mental Alertness Patients should be warned about engaging in activities requiring mental alertness such as driving a car or operating appliances, machinery, etc.
- Usage in the Elderly (approximately 60 years or older) Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients.
- Clemastine fumarate should be used with caution in patients with:
- history of bronchial asthma, increased intraocular pressure, hyperthyroidism, cardiovascular disease, and hypotension.
- Drug Interactions MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines.
Quoted from the official label, section “Warnings”.
Other medicines
MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines.
Quoted from the official label, section “Drug Interactions”.
If you take too much
In an emergency, call your local emergency number or a poison control centre.
- Antihistamine overdosage reactions may vary from central nervous system depression to stimulation.
- Stimulation is particularly likely in children.
- Atropine-like signs and symptoms:
- dry mouth; fixed, dilated pupils; flushing; and gastrointestinal symptoms may also occur.
- If vomiting has not occurred spontaneously the conscious patient should be induced to vomit.
- This is best done by having him drink a glass of water or milk after which he should be made to gag.
- Precautions against aspiration must be taken, especially in infants and children.
- If vomiting is unsuccessful gastric lavage is indicated within 3 hours after ingestion and even later if large amounts of milk or cream were given beforehand.
- Isotonic and 1/2 isotonic saline is the lavage solution of choice.
- Saline cathartics , such as milk of magnesia, by osmosis draw water into the bowel and therefore, are valuable for their action in rapid dilution of bowel content.
- Stimulants should not be used.
- Vasopressors may be used to treat hypotension.
Quoted from the official label, section “Overdosage”.
Side effects
- 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.
- Nervous System:
- Sedation, sleepiness, dizziness, disturbed coordination , fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesias, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, hysteria, neuritis, convulsions.
- GI System: Epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation.
- GU System: Urinary frequency, difficult urination, urinary retention, early menses.
- Respiratory System:
- Thickening of bronchial secretions, tightness of chest and wheezing, nasal stuffiness.
Quoted from the official label, section “Adverse Reactions”.
What it looks like and how it is packed
- Clemastine Fumarate Tablets USP, 2.68 mg are white, round, scored tablets debossed with "NH" and "268".
- Tablets are packaged in bottles of 30 (NDC 71085-081-30)
- Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
- Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Quoted from the official label, section “How Supplied”.
How to store it
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Quoted from the official label, section “Storage and Handling”.
What is in it
- Clemastine belongs to the benzhydryl ether group of antihistaminic compounds.
- The chemical name is (+)-(2R)-2-[2-[[(R)-p-Chloro-α-methyl-α-phenylbenzyl]-oxy]ethyl]-1-methylpyrrolidine fumarate (1:1).
- C 21 H 26 C1NO∙C 4 H 4 O 4 M.W.
- 459.97 Each tablet for oral administration contains 2.68 mg of clemastine fumarate, USP.
- Inactive ingredients:
- colloidal silicon dioxide, corn starch, lactose monohydrate, povidone, pregelatinized starch and stearic acid.
- Chemical structure
Quoted from the official label, section “Description”.
Ingredients people check for
Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.
- Lactose
lactose monohydrate
Milk sugar: matters with lactose intolerance or a milk allergy.
Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.
Every version of this medicine (2)
The same active substance, strength and kind of form, from every company that sells it — with what each label lists.
Showing 2 of 2
Details
| Made by | IPG Pharmaceuticals, Inc. |
|---|---|
| Active substance | Clemastine Fumarate |
| Strength | 2.68 mg |
| Form | Tablet |
| Route | Oral |
| Packs | 30 TABLET in 1 BOTTLE |
| NDC | 71085-081 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.