Guaifenesin and Dextromethorphan Hydrobromide

LLC Federal Solutions

FULL PRESCRIBING INFORMATION

Active ingredient

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

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

Purpose

Purpose of Guaifenesin:
Expectorant

Purpose of Dextromethorphan HBr:
Cough Suppressant

Uses

Uses

• temporarily relieves cough due to minor throat and bronchial irritation
• helps loosen phlegm (mucus)
• 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 this and all drugs out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• take every 4 hours, or as directed by a doctor
• do not take more than 6 doses in 24 hours

Other information
Store at room temperature between 15°-30°C (59°-86°F)
Does not cause drowsiness

Inactive ingredients
citric acid, strawberry flavor, glycerin, menthol, methylparaben, propylene glycol, saccharin sodium, sodium benzoate, sorbitol, water.

Questions
Call 1-855-333-6337

Repackaged by:
Safecor Health, LLC
317 New Boston St.
Woburn, MA 01801

Distributed by:
LLC Federal Solutions
14 NE 1st Ave.
Miami, FL 33132

Rev 102-00 07/2013

———PRINCIPAL DISPLAY PANEL———
NDC: 24451-133-05
guaiFENesin AND
DEXTROMETHORPHAN HBr
100 mg / 10 mg PER 5 mL
(SILTUSSIN-DM DAS COUGH FORMULA)
DELIVERS 5 mL
ALCOHOL /DYE/ SUGAR FREE
STRAWBERRY FLAVOR
Exp: 00/00/00       Lot # 00000

Rpk By: Safecor Health LLC
Woburn, MA 01801
Dist. By: LLC Federal Solutions
Miami, FL 33132