Label: CLEMASZ- clemastine fumarate tablet

Rx only

Clemastine belongs to the benzhydryl ether group of antihistaminic compounds. The chemical name is (+)-(2 R)-2-[2-[[( R)- p-Chloro-α-methyl-α-phenylbenzyl]-oxy]ethyl]-1-methylpyrrolidine fumarate (1:1).

C 21H 26C1NO∙C 4H 4O 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.

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. The inherently long duration of antihistaminic effects of clemastine fumarate has been demonstrated in wheal and flare studies. In normal human subjects who received histamine injections over a 24-hour period, the antihistaminic activity of clemastine reached a peak at 5 to 7 hours, persisted for 10 to 12 hours and, in some cases, for as long as 24 hours. Pharmacokinetic studies in man utilizing 3H and 14C labeled compound demonstrates that: clemastine is rapidly and nearly completely absorbed from the gastrointestinal tract, peak plasma concentrations are attained in 2 to 4 hours, and urinary excretion is the major mode of elimination.

CLEMASZ ™ (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. CLEMASZ ™ (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.

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.

Clemastine fumarate should be used with caution in patients with: history of bronchial asthma, increased intraocular pressure, hyperthyroidism, cardiovascular disease, and hypotension.

Transient drowsiness, the most common adverse reaction associated with clemastine fumarate, occurs relatively frequently and may require discontinuation of therapy in some instances.

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 spontaneouslythe 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.

Stimulantsshould notbe used.

Vasopressors may be used to treat hypotension.

DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND RESPONSE OF THE PATIENT.

CLEMASZ ™ (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 84044-268-03).

Manufactured For:
New HeightsRx, LLC
1225 Ave. Ponce de Leon PH - 1562
San Juan, Puerto Rico 00907

Rev. 04/2025

NDC 84044-268-03

Clemastine
Fumarate
Tablets, USP

2.68 mg

Rx only
30 Tablets

New HeightsRx, LLC.