SILTUSSIN DM- guaifenesin and dextromethorphan hydrobromide liquid

Siltussin DM by

Drug Labeling and Warnings

Siltussin DM by is a Otc medication manufactured, distributed, or labeled by Preferred Pharmaceuticals, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Guaifenesin 100 mg (in each 5 mL (teaspoon)(TSP))

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

PURPOSE

Purpose of Guaifenesin: Expectorant

Purpose of Dextromethorphan Hydrobromide: Cough Suppressant

INDICATIONS & USAGE

Uses

• temporarily relieves cough due to minor throat and bronchial irritation
  
• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  

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

• persistent cough or chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysema
• cough accompanied by excessive phlegm (mucus)
  

Stop use and ask a doctor if

• cough lasts more than 7 days or occurs with fever, rash, or headaches that lasts. This could be signs of a serious condition
• hypersensitive to any ingredients
  

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 6 doses in any 24-hour period. This adult product is not intended for use in children under 12 years of age

• Adults and children 12 years and over:

  2 teaspoonfuls (TSP); every 4 hours;

• Children under 12 years:

  DO NOT USE

INACTIVE INGREDIENT

Inactive ingredients

citric acid, FD&C red no. 40, glycerin, menthol, methylparaben, propylene glycol, saccharin sodium, sodium benzoate, strawberry flavor, sucrose, purified water.

Other information

store at room temperature 20°-25°C (68°-77°F)

QUESTIONS

Questions: 888-974-5279

Manufactured by

Silarx Pharmaceutical Inc,

1033 Stoneleigh Ave.
Carmel, NY 10512

Relabeled By: Preferred Pharmaceuticals Inc.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SILTUSSIN DM 
guaifenesin and dextromethorphan hydrobromide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68788-9103(NDC:54838-209)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	100 mg  in 5 mL
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS)	Dextromethorphan Hydrobromide	10 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C red no. 40 (UNII: WZB9127XOA)
glycerin (UNII: PDC6A3C0OX)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
methylparaben (UNII: A2I8C7HI9T)
propylene glycol (UNII: 6DC9Q167V3)
saccharin sodium (UNII: SB8ZUX40TY)
sodium benzoate (UNII: OJ245FE5EU)
sucrose (UNII: C151H8M554)
water (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	STRAWBERRY (STRAWBERRY FLAVOR)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68788-9103-1	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/05/1992

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/05/1992

Labeler - Preferred Pharmaceuticals, Inc (791119022)

Registrant - Preferred Pharmaceuticals, Inc (791119022)

Establishment
Name	Address	ID/FEI	Business Operations
Preferred Pharmaceuticals, Inc		791119022	RELABEL(68788-9103)