Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Rebel Distributors Corp
118802834
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sildec PE DM
Product Details
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
OVERDOSAGE SECTION
OVERDOSAGE
No information is available as to specific results of an overdose of CPM/PE/DM Syrup. The signs, symptoms and treatments 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 excitation, 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 arrhythmia, 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 phenylephrine. (j) Further care is symptomatic and supportive.