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Silphen DM Cough

Dosage form: liquid
Ingredients: Dextromethorphan Hydrobromide 10mg in 5mL
Labeler: Silarx Pharmaceuticals, Inc
NDC Code: 54838-105

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Silphen DM Cough Syrup

Active Ingredient: Dextromethorphan Hydrobromide 10 mg (in each 5 mL)

Purpose: Cough Suppressant

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold

Warnings

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. 

Ask a doctor before use if you have
  • a cough that occurs with too much phlegm (mucus)
  • a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if

cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache,. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions
  • do not take more than 4 doses in any 24-hour period

Adults and children 12 years of age and older
2 teaspoonfuls every 6 to 8 hours
Children under 12 yrs
Do not use
Other information
Store at room temperature 20°-25°C (68°-77°F).

Inactive ingredients

alcohol 5%, ammonium chloride, citric acid, D&C yellow No 10, FD&C blue no 1, FD&C red no.40, strawberry flavor, glycerin, menthol, methylparaben, sodium benzoate, sodium citrate, sucrose, purified water.

Questions

888-974-5279

Manufactured by:

Silarx Pharmaceuticals, Inc,
19 West Street,
Spring Valley, NY 10977 USA

SILPHEN DM COUGH 
dextromethorphan hydrobromide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54838-105
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
alcohol 
ammonium chloride 
anhydrous citric acid 
D&C yellow no. 10 
FD&C blue no. 1 
FD&C red no. 40 
glycerin 
menthol 
methylparaben 
sodium benzoate 
sodium citrate 
sucrose 
water 
Product Characteristics
Color    Score    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:54838-105-40118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/01/1987
Labeler - Silarx Pharmaceuticals, Inc (161630033)

Revised: 11/2011
 
Silarx Pharmaceuticals, Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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