Carbinoxamine Maleate Extended-Release Oral Suspension

Carbinoxamine Maleate extended-release oral suspension is 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

Extended-release oral suspension: 4 mg carbinoxamine maleate per 5 mL as a light beige to tan viscous suspension with strawberry-banana flavor.

Carbinoxamine Maleate Extended-Release Oral Suspension is contraindicated in:

• children younger than 2 years of age because deaths have been reported in this age group [see Warnings and Precautions (5.1)].
• patients who are hypersensitive to carbinoxamine maleate or any of the inactive ingredients in Carbinoxamine Maleate Extended-Release Oral Suspension [see Warnings and Precautions (5.4)].
• patients who are taking monoamine oxidase inhibitors (MAOI) [see Drug Interactions (7)].

The following clinically significant adverse reactions are described elsewhere in the labeling:

• Somnolence and Impaired Mental Alertness [see Warnings and Precautions (5.2)]
• Allergic Reactions due to Sulfites, including Anaphylaxis [see Warnings and Precautions (5.4)]

The most frequent adverse reactions include: sedation, sleepiness, dizziness, disturbed coordination, epigastic distress, and thickening of bronchial secretions. In clinical use, younger children and older adults may be particularly sensitive to adverse reactions [see Pediatric Use (8.4) and Geriatric Use (8.5)].

The following adverse reactions, listed by body system, have been identified in case reports and during the use of carbinoxamine in observational studies. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

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.

Central Nervous System: Fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomia, euphoria, paresthesia, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, hysteria, neuritis, convulsions.

Gastrointestinal: Anorexia, nausea, vomiting, diarrhea, constipation.
Hematologic: Hemolytic anemia, thrombocytopenia, agranulocytosis.

Laboratory: Increase in uric acid levels.
Respiratory: Tightness of chest and wheezing, nasal stuffiness.

Urogenital: Urinary frequency, difficult urination, urinary retention, early menses.

• Do not use Carbinoxamine Maleate extended-release oral suspension in patients who are taking monoamine oxidase inhibitors (MAOIs), which prolong and intensify the anticholinergic (drying) effects of antihistamines.
• Avoid use of Carbinoxamine Maleate extended-release oral suspension with alcohol and other CNS depressants (hypnotics sedatives, tranquilizers, etc.) due to additive effects.

Overdosage with carbinoxamine may cause central nervous system depression or stimulation, hallucinations, convulsions, and death. Atropine-like signs and symptoms – dry mouth; fixed, dilated pupils; flushing; and gastrointestinal symptoms may also occur.

The treatment of overdosage consists of discontinuation of Carbinoxamine Maleate extended-release oral suspension and institution of symptomatic and supportive therapy. 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.

Each 5 mL of Carbinoxamine Maleate extended-release oral suspension contains 4 mg carbinoxamine maleate (equivalent to 2.86 mg of carbinoxamine) complex with sodium polystyrene sulfonate.

Carbinoxamine Maleate extended-release oral suspension contains the following inactive ingredients: citric acid anhydrous, strawberry-banana flavor, glycerin, high fructose corn syrup, methylparaben, modified food starch, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, triacetin, and xanthan gum.

The chemical name of carbinoxamine maleate is 2-[(4-chlorophenyl)-2- pyridinylmethoxy]-N, N-dimethylethanamine (Z)-2-butenedioate (1:1), which has the following structure:

structure 1

Structure 2

The effectiveness and safety of Carbinoxamine Maleate extended-release oral suspension is based on demonstration of bioequivalence to the immediate-release reference product [see Pharmacokinetics (12.3)].

• Carbinoxamine Maleate extended-release oral suspension contains 4 mg carbinoxamine maleate per 5 mL.

It is a light beige to tan viscous suspension with strawberry banana flavor and is supplied as follows:

NDC 62542-101-05 Bottles of 16 fl oz (480 mL)

• Store at 25ºC (77ºF); excursions permitted from 15ºC to 30ºC (59ºF to 86ºF). [See USP Controlled Room Temperature].

• Dispense in tight, light-resistant container with child-resistant closure.

Administration

• Advise patients to measure Carbinoxamine Maleate extended-release oral suspension with an accurate milliliter measuring device. A household teaspoon is not an accurate measuring device and could lead to overdosage [ see Dosage and Administration (2.2)].
• Instruct patients to shake Carbinoxamine Maleate extended-release oral suspension well before use.

Activities Requiring Mental Alertness

Advise patients to use caution when driving a motor vehicle or operating machinery. Carbinoxamine Maleate extended-release oral suspension 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 [see Warnings and Precautions (5.2)].

Alcohol, Sedatives, and Tranquilizers

Advise patients to avoid the use of alcoholic beverages, sedatives, and tranquilizers while taking Carbinoxamine Maleate extended-release oral suspension because additional reduction in mental alertness may occur [see Warnings and Precautions (5.2) and Drug Interactions (7)].

MAOIs

Advise patients to not use MAOIs while taking Carbinoxamine Maleate extended-release oral suspension. MAOIs may prolong and intensify the anticholinergic (drying) effects [see Contraindications (4) and Drug Interactions (7)].

Lactation

Advise women that breastfeeding is not recommended during treatment with Carbinoxamine Maleate extended-release oral suspension [see Warnings and Precautions (5.1) and Use in Specific Populations (8.2)].

PRINCIPAL DISPLAY PANEL - 480 mL Bottle Label

NDC 62542-101-05

Carbinoxamine Maleate Extended-Release Oral Suspension

4 mg/5ml

Shake Well Before Use

Dose every 12 hours

Dispense with an accurate millimeter measuring device

Strawberry Banana Flavored

Rx only 16 fl oz. (480 mL)

Karbinal-Label-16oz

Manufactured by:
Tris Pharma, Inc.
Monmouth Junction, NJ 08852

For:

new logo

Neos Therapeutics, LP

Denver, CO 80237

LB8788

Rev. 01

03/2026