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Guaifenesin and Dextromethorphan Hydrobromide

Medically reviewed on August 13, 2018

Dosage form: liquid
Ingredients: GUAIFENESIN 100mg in 5mL, DEXTROMETHORPHAN HYDROBROMIDE 10mg in 5mL
Labeler: LLC Federal Solutions
NDC Code: 24451-133

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.

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

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

Purpose of Guaifenesin:
Expectorant

Purpose of Dextromethorphan HBr:
Cough Suppressant

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
Adult and children 12 years and over2 teaspoonfuls (TSP)
Children under 12 yearsDO NOT USE

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

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE 
guaifenesin and dextromethorphan hydrobromide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24451-133(NDC:54838-133)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
GLYCERIN 
MENTHOL 
METHYLPARABEN 
PROPYLENE GLYCOL 
SACCHARIN SODIUM 
SODIUM BENZOATE 
SORBITOL 
WATER 
Product Characteristics
Color    Score    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:24451-133-05100 CUP, UNIT-DOSE (CUP) in 1 BOX
15 mL in 1 CUP, UNIT-DOSE
2NDC:24451-133-10100 CUP, UNIT-DOSE (CUP) in 1 BOX
210 mL in 1 CUP, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/08/2013
Labeler - LLC Federal Solutions (965036895)
Establishment
NameAddressID/FEIOperations
Safecor Health, LLC828269675repack(24451-133)

 
LLC Federal Solutions

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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