DESCRIPTION

CARBINOXAMINE - PSEUDOEPHEDRINE - DEXTROMETHORPHAN DROPS (C.P. - DM DROPS)

Antihistamine/Decongestant/Antitussive for oral use.
C.P. DM DROPS- SUGAR FREE, ALCOHOL FREE
For infants, for oral use:
Each dropperful (1 mL) contains carbinoxamine maleate, 1 mg; pseudoephedrine hydrochloride, 15 mg; dextromethorphan hydrobromide, 4 mg.
INACTIVE INGREDIENTS: Citric Acid Glycerin, Sodium Benzoate, Sorbitol, D&C Red No. 33, FD&C Blue No. 1, Artificial and Natural Flavoring and Purified Water.

CLINICAL PHARMACOLOGY

Antihistaminic, decongestant and antitussive actions
Carbinoxamine maleate possesses H1 antihistaminic activity and mild anticholinergic and sedative effects. Serum half-life for carbinoxamine is estimated to be 10 to 20 hours.
Virtually no intact drug is excreted in the urine.
Pseudoephedrine hydrochloride is an oral sympathomimetic amine which acts as a decongestant to respiratory tract mucous membranes. While its vasoconstrictor action is similar to that of ephedrine, pseudoephedrine has less presser effect in normotensive adults. Serum half-life for pseudoephedrine is 6 to 8 hours. Acidic urine is associated with faster elimination of the drug. About one half of the administered dose is excreted in the urine.
Dextromethorphan hydrobromide is a nonnarcotic antitussive with effectiveness equal to codeine, It acts in the medulla oblongata to elevate the cough threshold. Dextromethorphan does not produce analgesia or induce tolerance, and has no potential for addiction. At usual doses, it will not depress respiration or inhibit ciliary activity. Dextromethorphan is rapidly metabolized, with trace amounts of the parent compound in blood and urine. About one half of the administered dose is excreted in the urine as conjugated metabolites.

CLINICAL STUDIES

INDICATIONS AND USAGE

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

CONTRAINDICATIONS

Patients with hypersensitivity or idiosyncrasy to any ingredients, patients taking monoamine oxidase (MAO) inhibitors, patients with narrow-angle glaucoma, urinary retention, peptic ulcer, severe hypertension or coronary artery disease, or patients undergoing asthmatic attack. 

WARNINGS

Use in Pregnancy: Safety for use during pregnancy has not been established.
Nursing Mothers: Use with caution in nursing mothers.
Special Risk Patients: Use with caution in patients with hypertension or ischemic heart disease, and persons over 60 years.

PRECAUTIONS

ADVERSE REACTIONS

Antihistamines: Sedation, dizziness, diplopia, vomiting, diarrhea, dry mouth, headache, nervousness, nausea, anorexia, heartburn, weakness, polyuria and dysuria and, rarely, excitability in children.
Sympathomimetic Amines: Convulsions, CNS stimulation, cardiac arrythmias, respiratory difficulty, increased heart rate or blood pressure, hallucinations, tremors, nervousness, insomnia, weakness, pallor and dysuria.
Dextromethorphan: Drowsiness and GI disturbance.

OVERDOSAGE

No information is available as to specific results of an overdose of these products. The signs, symptoms and treatment described below are those of H1 antihistamine, ephedrine and dextromethorphan overdose. Symptoms: Should antihistamine effects predominate, central action constitutes the greatest danger. In the small child, predominant symptoms are excitdtion, hallucination, ataxia, incoordination, tremors, flushed face and fever. Convulsions, fixed and dilated pupils, coma, and death may occur in severe cases. In the adult, fever and flushing are uncommon; excitement leading to convulsions and postictal depression is often preceded by drowsiness and coma. Respiration is usually not seriously depressed; blood pressure is usually stable. Should sympathomimetic symptoms predominate, central effects include restlessness, dizziness, tremor, hyperactive reflexes, talkativeness, irritability and insomnia. Cardiovascular and renal effects include difficulty in micturition, headache, flushing, palpitation, cardiac arrythmias, hypertension with subsequent hypotension and circulatory collapse. Gastrointestinal effects include dry mouth, metallic taste, anorexia, nausea, vomiting, diarrhea and abdominal cramps.
Dextromethorphan may cause respiratory depression with a large overdose.
Treatment: a) Evacuate stomach as condition warrants. Activated charcoal may be useful. b) Maintain a nonstimulating environment. c) Monitor cardiovascular status. d) Do not give stimulants. e) Reduce fever with cool sponging. f) Treat respiratory depression with naloxone if dextromethorphan toxicity is suspected. g) Use sedatives or anticonvulsants to control CNS excitation and convulsions. h) Physostigmine may reverse anticholinergic symptoms. I) Ammonium chloride may acidify the urine to increase urinary excretion of pseudoephedrine. j) Further care is symptomatic and supportive. 

DOSAGE AND ADMINISTRATION

AGE DOSE* FREOUENCY*
C.P. - DM DROPS
for oral use only
1-3 months 1/4 dropperful (1/4 mL) q.i.d.
3-6 months 1/2 dropperfUl (1/2 mL) q.i.d.
6-9 months 3/4 dropperful (3/4 mL) q.i.d.
9-18 months 1 dropperful (1 mL) q.i.d.
*ln mild cases or in particularly sensitive patients, less frequent or reduced doses may be adequate.

HOW SUPPLIED

C.R - DM Drops, grape flavored, are supplied in 30 mL bottles NDC 54868-4727-0, with calibrated dropper. Avoid exposure to excessive heat.

REFERENCES

Rx only.
Manufactured by:
TRI-MED LABORATORIES, INC.
Somerset, NJ 08873 Rev. 1 2-01
MG #16535

Distributed by:

MAJOR PHARMACEUTICALS

Livonia, MI 48150

Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma       74146

PRINCIPAL DISPLAY PANEL