May 23, 2017
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Karbinal ER

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Karbinal ER



Included as part of the PRECAUTIONS section.


Pediatric Mortality

Deaths have been reported in children less than 2 years of age who were taking carbinoxamine containing drug products; therefore, Karbinal ER is contraindicated in children younger than 2 years of age.

Activities Requiring Mental Alertness

Karbinal ER may produce marked drowsiness and impair the mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Advise patients to avoid engaging in hazardous tasks requiring mental alertness and motor coordination after ingestion of Karbinal ER. Avoid concurrent use of Karbinal ER with alcohol or other central nervous system depressants because additional impairment of central nervous system performance may occur.

Concomitant Medical Conditions

Karbinal ER has anticholinergic (atropine-like) properties and, therefore, should be used with caution in patients with: increased intraocular pressure, narrow angle glaucoma, hyperthyroidism, cardiovascular disease, hypertension, stenosing peptic ulcer, symptomatic prostatic hypertrophy, bladder neck obstruction, or pyloroduodenal obstruction.

Allergic Reactions Due To Sulfites

Karbinal ER contains sodium metabisulfite, a sulfite that may cause allergic-type reactions, including anaphylaxis and life-threatening or less severe asthmatic episodes, in susceptible individuals. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic individuals.


Advise patients to measure Karbinal ER with an accurate milliliter measuring device. A household teaspoon is not an accurate measuring device and could lead to overdosage. A pharmacist can recommend an appropriate measuring device and can provide instructions for measuring the correct dose.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

No long-term studies in animals have been performed to determine the possible effects of carbinoxamine on carcinogenesis, mutagenesis, and fertility.

Use In Specific Populations


Pregnancy Category C. Animal reproductive studies have not been conducted with carbinoxamine maleate. It is also not known whether Karbinal ER can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Karbinal ER should be given to a pregnant woman only if clearly needed.

Labor And Delivery

The effect of Karbinal ER on labor and delivery is not known.

Nursing Mother

Because of the risk of mortality in infants given carbinoxamine-containing drugs, use of Karbinal ER is contraindicated in nursing mothers.

Pediatric Use

Deaths have been reported in children younger than 2 years of age who were taking carbinoxaminecontaining drug products. Therefore, Karbinal ER is contraindicated in children younger than 2 years of age and in nursing mothers. Carbinoxamine may diminish mental alertness or produce sedation in children. Paradoxical reactions with excitation are more likely in younger children.

Geriatric Use

Karbinal ER may cause dizziness, hypotension, confusion, or over-sedation in the elderly. Start elderly patients on lower doses and observe closely.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 3/30/2017


Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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