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Sildec PE DM

CHLORPHENIRAMINE / PHENYLEPHRINE/ DEXTROMETHORPHAN Syrup (CPM/PE/DM Syrup)

Approved
Approval ID

545ae063-21bf-4dc8-9ad0-0c113b1b0dea

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 13, 2011

Manufacturers
FDA

Rebel Distributors Corp

DUNS: 118802834

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Sildec PE DM

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21695-900
Product Classification
G
Generic Name
Sildec PE DM
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 26, 2011
FDA Product Classification

INGREDIENTS (12)

CHLORPHENIRAMINE MALEATEActive
Quantity: 4 mg in 5 mL
Code: V1Q0O9OJ9Z
Classification: ACTIB
PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 12.5 mg in 5 mL
Code: 04JA59TNSJ
Classification: ACTIB
DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 15 mg in 5 mL
Code: 9D2RTI9KYH
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT

Drug Labeling Information

OVERDOSAGE SECTION

LOINC: 34088-5Updated: 5/5/2009

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.

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Sildec PE DM - FDA Drug Approval Details