SILPHEN DM COUGH- dextromethorphan hydrobromide liquid

Silphen DM Cough by

Drug Labeling and Warnings

Silphen DM Cough by is a Otc medication manufactured, distributed, or labeled by Lannett Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SILPHEN DM COUGH 
dextromethorphan hydrobromide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54838-105
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
AMMONIUM CHLORIDE (UNII: 01Q9PC255D)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54838-105-40	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/1987

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	12/01/1987

Labeler - Lannett Company, Inc. (161630033)