Silphen DM Cough description, usages, side effects, indications, overdosage, supplying and lots more!

Silphen DM Cough

Silarx Pharmaceuticals, Inc

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Silphen DM Cough Syrup

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

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

Purpose

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

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 Type Human otc drug label Item Code (Source) NDC:54838-105
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 10 mg

Inactive Ingredients

Ingredient Name Strength
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

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54838-105-40 118 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 1987-12-01


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Be sure to consult your doctor before taking any medication!
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