Dimetane Expectorant-C (Brompheniramine Maleate)

DIMETANE® EXPECTORANT-C DIMETANE® EXPECTORANT-DC

Whitehall-Robins

Brompheniramine Maleate – Phenylephrine HCl – Phenylpropanolamine HCl – Guaifenesin – Codeine Phosphate

Brompheniramine Maleate – Phenylephrine HCl – Phenylpropanolamine HCl – Guaifenesin – Hydrocodone Bitartrate

Antihistamine – Decongestant – Expectorant – Antitussive

Indications And Clinical Uses: The temporary relief of coughing and the complications of allergic states including manifestations such as perennial and seasonal allergic rhinitis. The symptomatic relief of cough, nasal stuffiness and rhinitis accompanying the common cold and other upper respiratory tract infections.

Contra-Indications: Hypersensitivity to any of the ingredients and patients receiving MAO inhibitors. Should not be used to treat lower respiratory tract symptoms including asthma.

Precautions: Before prescribing medication to suppress or modify cough, it is important to ascertain that the underlying cause of the cough is identified, that modification of the cough does not increase the risk of clinical or physiologic complications, and that appropriate therapy for the primary disease is provided.

Administer with caution to patients with cardiac or peripheral vascular disease, glaucoma, hyperthyroidism, diabetes mellitus or hypertension, chronic lung disease or shortness of breath, prostate enlargement and bladder neck obstruction and in pregnancy or lactation.

Occupational Hazards: Patients should be cautioned not to operate vehicles or hazardous machinery until their response to the drug has been determined. Since the depressant effects of antihistamines are additive to those of other drugs affecting the CNS, patients should be cautioned against drinking alcoholic beverages or taking hypnotics, sedatives, psychotherapeutic agents or other drugs with CNS depressant effects during antihistaminic therapy.

Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

Dimetane Expectorant-DC: In young children the respiratory centre is especially susceptible to the depressant action of narcotic cough suppressants. Benefit-to-risk ratio should be carefully considered especially in children with respiratory embarrassment, e.g., croup. Estimation of dosage relative to the child’s age and weight is of great importance.

Pregnancy: Since hydrocodone crosses the placental barrier, its use in pregnancy is not recommended.

As hydrocodone may inhibit peristalsis, patients with chronic constipation should be given Dimetane Expectorant-DC only after weighing the potential therapeutic benefit against the hazards involved.

Dimetane Expectorant-C contains codeine – may produce drug dependence.

Dimetane Expectorant-DC contains hydrocodone – may be habit forming.

Adverse Reactions: Hypersensitivity reactions to brompheniramine maleate, including skin rashes, urticaria, hypotension and thrombocytopenia may occur rarely. Drowsiness, lassitude, nausea, giddiness, dryness of the mouth, mydriasis, increased irritability or excitement may be encountered.

Symptoms And Treatment Of Overdose: Symptoms: May vary from CNS depression to stimulation. Stimulation is particularly likely in children as a result of antihistamine overdosage. Atropine-like signs and symptoms such as dry mouth, fixed, dilated pupils, flushing and gastrointestinal symptoms may also occur.

Treatment: If vomiting has not occurred spontaneously, the patient should be induced to vomit. This is best done by administering syrup of ipecac. 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. Emesis or lavage should be followed by the administration of activated charcoal. Stimulants should not be used. Vasopressors may be used to treat hypotension. Naloxone may be used to treat codeine or hydrocodone toxicity.

Dosage And Administration: Dimetane Expectorant-C: Adults: 5 to 10 mL every 6 hours. Children 6 to 12 years: 2.5 to 5 mL every 6 to 8 hours.

Dimetane Expectorant-DC: Adults: 5 to 10 mL every 6 hours. Children 6 to 12 years: 2.5 to 5 mL every 6 hours.

Availability And Storage: Dimetane Expectorant-C: Each 5 mL of palatable, cherry-red liquid, menthol and raspberry taste and odor, contains: brompheniramine maleate 2 mg, phenylephrine HCl 5 mg, phenylpropanolamine HCl 5 mg, guaifenesin 100 mg and codeine phosphate 10 mg. Nonmedicinal ingredients: alcohol, citric acid, D&C Red No. 33, FD&C Red No. 40, flavors, glycerin, invert sugar, sodium benzoate and water. Energy: 15.3 kJ (3.65 kcal)/5 mL.
Dimetane Expectorant-DC: Each 5 mL of cherry-red liquid, menthol and raspberry taste and odor, contains: hydrocodone bitartrate 1.8 mg, brompheniramine maleate 2 mg, phenylephrine HCl 5 mg, phenylpropanolamine HCl 5 mg and guaifenesin 100 mg. Nonmedicinal ingredients: alcohol, citric acid, D&C Red No. 33, FD&C Red No. 40, flavors, glycerin, invert sugar, sodium benzoate and water. Energy: 15.3 kJ (3.65 kcal)/5 mL. Sodium:

DIMETANE® EXPECTORANT-C DIMETANE® EXPECTORANT-DC Whitehall-Robins Brompheniramine Maleate – Phenylephrine HCl – Phenylpropanolamine HCl – Guaifenesin – Codeine PhosphateBrompheniramine Maleate – Phenylephrine HCl – Phenylpropanolamine HCl – Guaifenesin – Hydrocodone Bitartrate Antihistamine – Decongestant – Expectorant – Antitussive

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