Data from FDA - Curated by EPG Health - Last updated 27 July 2017

Indication(s)

INDICATIONS AND USAGE For relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.

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Advisory information

contraindications
CONTRAINDICATIONS Patients with hypersensitivity or idiosyncrasy to any of its ingredients. Sympathomimetic amines are contraindicated in patients with severe hypertension, severe coronary artery disease and patients on monoamine oxidase (MAO) inhibitor therapy. Antihistamines are contraindicated in patients with narrow angle glaucoma, urinary retention, peptic ulcer and during an asthma attack. Dextromethorphan should not be used in patients receiving a monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping the MAOI drug.
Special warnings and precautions
PRECAUTIONS General: Before prescribing medication to suppress or modify cough, identify and provide therapy for the underlying cause of the cough and take caution that modification of cough does not increase the risk of clinical or physiologic complications. Dextromethorphan should be used with caution in sedated or debilitated patients and in patients confined to supine positions. Use with caution in patients with hypertension, heart disease, asthma, hyperthyroidism, increased intraocular pressure, diabetes mellitus and prostatic hypertrophy. Information for Patients: Avoid alcohol and other CNS depressants while taking this product. Patients sensitive to antihistamines may experience moderate to severe drowsiness. Patients sensitive to sympathomimetic amines may notice mild CNS stimulation. Antihistamines may impair mental and physical abilities required for the performance of potentially hazardous tasks such as driving a vehicle or operating machinery. Patients should be warned accordingly. Drug Interactions: Antihistamines may enhance the effects of tricyclic antidepressants, barbiturates, alcohol and other CNS depressants. MAO inhibitors prolong and intensify the anticholinergic effects of antihistamines. Sympathomimetic amines may reduce the antihypertensive effects of reserpine, veratrum alkaloids, methyldopa and mecamylamines. Effects of sympathomimetics are increased with MAO inhibitors and beta-adrenergic blockers. The cough-suppressant action of dextromethorphan and narcotic antitussives are additive. Dextromethorphan is contraindicated with monoamine oxidase inhibitors (MAOI). (See CONTRAINDICATIONS section.) Use in Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted with CPM/PE/DM Syrup. It is not known whether these products can cause fetal harm when administered to a pregnant woman or affect reproduction capacity. Give to a pregnant woman only if clearly needed. Nursing Mothers: It is not known whether the drugs in CPM/PE/DM Syrup are excreted in human milk. Since many drugs are excreted in human milk and because of the potential for serious side effects in nursing infants, a decision should be made whether to discontinue nursing or discontinue the use of these products, taking into account the importance of the drug to the mother.
Adverse reactions
ADVERSE REACTIONS Antihistamines may cause sedation, dizziness, diplopia, vomiting, diarrhea, dry mouth, headache, nervousness, nausea, anorexia, heartburn, weakness, polyuria and dysuria and, rarely, excitability in children. Urinary retention may occur in patients with prostatic hypertrophy. Sympathomimetic amines may cause convulsions, CNS stimulation, cardiac arrhythmia, respiratory difficulties, increased heart rate or blood pressure, hallucinations, tremors, nervousness, insomnia, pallor and dysuria. Dextromethorphan may cause drowsiness, dizziness and GI disturbance.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION CHLORPHENIRAMINE / PHENYLEPHRINE/ DEXTROMETHORPHAN Syrup (CPM/PE/DM Syrup) Adults and Children 12 years of age and older: 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonfuls in 24 hours. Children 6 to under 12 years of age: 1/2 teaspoonful (2.5 mL) every 4 to 6 hours, not to exceed 3 teaspoonfuls in 24 hours. Children 2 to under 6 years of age: 1/4 teaspoonful (1.25 mL) every 4 to 6 hours, not to exceed 1.5 teaspoonfuls in 24 hours. Not recommended for use in children under 2 years of age. In mild cases or in particularly sensitive patients, less frequent or reduced doses may be appropriate and adequate.
Pregnancy and lactation
Nursing Mothers: It is not known whether the drugs in CPM/PE/DM Syrup are excreted in human milk. Since many drugs are excreted in human milk and because of the potential for serious side effects in nursing infants, a decision should be made whether to discontinue nursing or discontinue the use of these products, taking into account the importance of the drug to the mother.

Interactions

Drug Interactions: Antihistamines may enhance the effects of tricyclic antidepressants, barbiturates, alcohol and other CNS depressants. MAO inhibitors prolong and intensify the anticholinergic effects of antihistamines. Sympathomimetic amines may reduce the antihypertensive effects of reserpine, veratrum alkaloids, methyldopa and mecamylamines. Effects of sympathomimetics are increased with MAO inhibitors and beta-adrenergic blockers. The cough-suppressant action of dextromethorphan and narcotic antitussives are additive. Dextromethorphan is contraindicated with monoamine oxidase inhibitors (MAOI). (See CONTRAINDICATIONS section.)

More information

Category Value
Agency product number V1Q0O9OJ9Z
Orphan designation No
Product NDC 21695-900
Date Last Revised 13-04-2011
Type HUMAN PRESCRIPTION DRUG
RXCUI 1251185
Storage and handling STORAGE REQUIREMENTS Store at Controlled Room Temperature between 20°-25°C (68°-77°F); excursions permitted to 15°- 30°C (59°-86°F) [See USP Controlled Room Temperature]. Avoid exposure to heat. Keep tightly closed. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Manufactured by: Silarx Pharmaceuticals, Inc. Spring Valley, NY 10977 USA Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320
Marketing authorisation holder Rebel Distributors Corp