Sildec PE DM Syrup

Name: Sildec PE DM Syrup

Indications and Usage for Sildec PE DM Syrup

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

Sildec PE DM Syrup 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.

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

Sildec PE DM Syrup 
Sildec PE DM Syrup syrup
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:54838-544
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Chlorpheniramine maleate (Chlorpheniramine) Chlorpheniramine maleate 4 mg  in 5 mL
Phenylephrine hydrochloride (Phenylephrine) Phenylephrine hydrochloride 12.5 mg  in 5 mL
Dextromethorphan hydrobromide (Dextromethorphan) Dextromethorphan hydrobromide 15 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
anhydrous citric acid  
D&C Red No. 33  
FD&C Blue No. 1  
glycerin  
sodium benzoate  
saccharin sodium  
sorbitol  
sodium citrate  
water  
Product Characteristics
Color      Score     
Shape Size
Flavor GRAPE (grape flavor) Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:54838-544-80 473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved other 01/05/2006
Labeler - Silarx Pharmaceuticals, Inc (161630033)
Revised: 05/2009   Silarx Pharmaceuticals, Inc
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