Carbinoxamine maleate

What Carbinoxamine maleate is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Carbinoxamine maleate is effective 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. …

— FDA label: Carbinoxamine Maleate, Genus Lifesciences Inc., effective March 6, 2024. Read the full label on DailyMed →

Label quoted: the one for the most common form (tablet, oral), Carbinoxamine Maleate, Genus Lifesciences Inc.; it covers 2 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.

The FDA has 8 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

0 of 8 FDA labels for this medicine have a boxed warning.

Carbinoxamine maleate side effects

Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.

The most frequent adverse reactions are underlined: Body as a Whole: Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose and throat. Cardiovascular: Hypotension, headache, palpitations, tachycardia, extrasystoles. Hematologic: Hemolytic anemia, thrombocytopenia, agranulocytosis.

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Central Nervous System: Sedation, sleepiness, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesia, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, hysteria, neuritis, convulsions. Gastrointestinal: Epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation. Urogenital: Urinary frequency, difficult urination, urinary retention, early menses. Respiratory: Thickening of bronchial secretions, tightness of chest and wheezing, nasal stuffiness. To report SUSPECTED ADVERSE REACTIONS, contact Allucent at 1-866-511-6754 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

— FDA label: Carbinoxamine Maleate, Genus Lifesciences Inc., effective March 6, 2024. Read the full label on DailyMed →

Carbinoxamine maleate drug interactions

Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.

Monoamine oxidase inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines. Carbinoxamine maleate has additive effects with alcohol and other CNS depressants (hypnotics sedatives, tranquilizers, etc.).

— FDA label: Carbinoxamine Maleate, Genus Lifesciences Inc., effective March 6, 2024. Read the full label on DailyMed →

Carbinoxamine maleate dosage

Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.

Carbinoxamine maleate is contraindicated in children younger than 2 years of age (see CONTRAINDICATIONS). Carbinoxamine maleate should be taken on an empty stomach with water. DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT. Carbinoxamine maleate dosage should be based on the severity of the condition and the response of the patient.

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The drug is well tolerated in adults in doses as high as 24 mg daily, in divided doses, over prolonged periods. On the other hand, some patients respond to as little as 4 mg daily. Clinical experience suggests the following dosage schedules: Tablets Usual Adult Dosage: 1 or 2 tablets (4 to 8 mg) 3 to 4 times daily Usual Child's Dosage: Six to eleven years – ½ to 1 tablet (2 to 4 mg) 3 to 4 times daily. Oral Solution Usual Adult Dosage: 1 or 2 teaspoonfuls (4 to 8 mg) 3 to 4 times daily Usual Child's Dosage (approximately 0.2 to 0.4 mg/kg/day, divided into 3 to 4 doses): Six to eleven years– ½ to 1 teaspoonful (2 to 4 mg) 3 to 4 times daily. Dosing for children 2 to 5 years of age should be based on weight whenever possible. The usual dosage for children 2 to 5 years of age is approximately 0.2 to 0.4 mg/kg/day, divided into 3 to 4 daily doses. In general, this corresponds to a dose of ¼ to ½ teaspoonful (1 to 2 mg) 3 to 4 times daily.

— FDA label: Carbinoxamine Maleate, Genus Lifesciences Inc., effective March 6, 2024. Read the full label on DailyMed →

Carbinoxamine maleate in pregnancy

Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.

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

— FDA label: Carbinoxamine Maleate, Genus Lifesciences Inc., effective March 6, 2024. Read the full label on DailyMed →

Carbinoxamine maleate and breastfeeding

Quoted from the nursing mothers / lactation part of the FDA-approved label.

Because of the higher risk of antihistamines for infants generally and for newborns and prematures in particular, use of carbinoxamine maleate is contraindicated in nursing mothers (see CONTRAINDICATIONS section).

— FDA label: Carbinoxamine Maleate, Genus Lifesciences Inc., effective March 6, 2024. Read the full label on DailyMed →

When Carbinoxamine maleate should not be used

Quoted from the “Contraindications” section of the FDA-approved label.

Carbinoxamine maleate is contraindicated in children younger than 2 years of age. Carbinoxamine maleate is contraindicated in nursing mothers. Carbinoxamine maleate is contraindicated in patients who are hypersensitive to the drug or on monoamine oxidase inhibitor therapy. (See Drug Interactions section).

— FDA label: Carbinoxamine Maleate, Genus Lifesciences Inc., effective March 6, 2024. Read the full label on DailyMed →

Carbinoxamine maleate overdose

Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).

Manifestations 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. Especially in infants and children, antihistamine overdosage may cause hallucinations, convulsions, or death.

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The oral LD 50 of carbinoxamine maleate in guinea pigs is 411 mg/kg. Treatment The treatment of overdosage with carbinoxamine maleate is essentially symptomatic and supportive. Vital signs (including respiration, pulse, blood pressure, and temperature) and EKG should be monitored. Induction of vomiting is not recommended. Activated charcoal should be given and gastric lavage should be considered after ingestion of a potentially life-threatening amount of drug. In the presence of severe anticholinergic effects, physostigmine may be useful. Vasopressors may be used to treat hypotension.

— FDA label: Carbinoxamine Maleate, Genus Lifesciences Inc., effective March 6, 2024. Read the full label on DailyMed →

Forms and how it is given

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

• Genus Lifesciences Inc.2 products
• BluCrest Pharmaceuticals, LLC1 product
• Leading Pharma, LLC1 product
• Aytu Therapeutics, LLC1 product
• Neos Therapeutics, LP1 product
• Tripoint Therapeutics, LLC1 product
• IPG Pharmaceuticals, Inc.1 product
• Carwin Pharmaceutical Associates, LLC1 product
• BioComp Pharma, Inc.1 product

FDA approval history

• NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
• ANDA: Abbreviated New Drug Application: how a generic version is approved.

Generic approvals (5)

• ANDA040442Genus Lifesciences · March 19, 2003
• ANDA040458Genus · April 25, 2003
• ANDA090756Mission Pharmacal · May 27, 2011
• ANDA207484Pharmobedient · May 31, 2016
• ANDA215476Leading · December 19, 2024

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

Next steps

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• Genus Lifesciences Inc.Maker or distributor
• BluCrest Pharmaceuticals, LLCMaker or distributor
• Leading Pharma, LLCMaker or distributor
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Sources

1. FDA-approved label on DailyMed (National Library of Medicine) — Carbinoxamine Maleate, Genus Lifesciences Inc., effective March 6, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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