Karbinal® ER (carbinoxamine maleate) extended-release oral suspension is an H1 receptor antagonist indicated for adults and pediatric patients 2 years of age and older for the symptomatic treatment of seasonal and perennial allergic rhinitis.
Karbinal® ER
(carbinoxamine maleate)—
Proven symptomatic allergy relief for kids
Karbinal ER is an antihistamine with anticholinergic effect.
  • Anticholinergic drugs exhibit drying properties which block the body’sallergy-causing symptoms1
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Features:
  • Effective antihistamine with anticholinergic effect
  • Broad indications and symptom relief
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Child-friendly, liquid formulation
  • Strawberry-banana flavor
  • Convenient option for children as young as 2 years of age
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Convenient, twice-daily dosing
  • 12-hour oral suspension carbinoxamine
  • The plasma half-life of carbinoxamine is 17 hours2
Approval of Karbinal ER (carbinoxamine maleate) extended-release oral suspension was based on the demonstration of bioequivalence to the previously approved immediate-release form of carbinoxamine maleate suspension.

Adverse Reactions

The most frequent adverse reactions include; sedation, sleepiness, dizziness, disturbed coordination, epigastric distress, and thickening of bronchial secretions. In clinical use, younger children and older adults may be particularly sensitive to adverse reactions.

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References: 1. Mayo Clinic. Antihistamine, Decongestant, And Anticholinergic Combination (Oral Route). mayoclinic.org. Updated November 01, 2023. Accessed November 14, 2023. https://shorturl.at/ivJV6. 2. Karbinal ER Prescribing Information. Denver, CO: Aytu BioPharma, Inc.; 03/2026.

IMPORTANT SAFETY INFORMATION

Karbinal ER (carbinoxamine maleate) extended-release oral suspension is an H1 receptor antagonist indicated for adults and pediatric patients 2 years of age and older for the symptomatic treatment of:

  • Seasonal and perennial allergic rhinitis
  • Vasomotor rhinitis
  • Allergic conjunctivitis due to inhalant allergens and foods
  • Mild, uncomplicated allergic skin manifestations of urticaria and angioedema
  • Dermatographism
  • As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled
  • Amelioration of the severity of allergic reactions to blood or plasma

Contraindications

  • Children younger than 2 years of age because deaths have been reported in this age group.
  • Patients who are hypersensitive to carbinoxamine maleate or any of the inactive ingredients in Karbinal ER.
  • Patients taking monoamine oxidase inhibitors (MAOIs). Do not use Karbinal ER in patients who are taking MAOIs, which prolong and intensify the anticholinergic (drying) effects of antihistamines.

Warnings and Precautions

  • Pediatric Mortality: Deaths have been reported in children less than 2 years of age who were taking carbinoxamine-containing products; therefore, Karbinal ER is contraindicated in children younger than 2 years of age.
  • Somnolence and Impaired 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, including Anaphylaxis: 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.
  • Lactation: Advise women breastfeeding is not recommended during treatment with Karbinal ER.

Adverse Reactions

The most frequent adverse reactions include; sedation, sleepiness, dizziness, disturbed coordination, epigastric distress, and thickening of bronchial secretions. In clinical use, younger children and older adults may be particularly sensitive to adverse reactions.