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Cough and Congestion DM by Velocity Pharma

Medically reviewed on September 6, 2018

Dosage form: capsule, liquid filled
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 10mg, GUAIFENESIN 200mg
Labeler: Velocity Pharma
NDC Code: 76168-060

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.

Dextromethorphan HBr (Cough Supressant)

Active Ingredient

(in each liquid filled capsule)

Dextromethorphan Hydrobromide, USP 10mg

Guaifenesin, USP 200mg

Purpose

Cough Suppressant

Expectorant

Uses
  • Temporarily relieves cough due minor throat and bronchial irritation as may occur with a cold
  • Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Directions
  • Do not take more than 12 capsules in any 24 hour period
  • This adult product is not intend for use in children under 12 years of age
                               Age              dose
    Adults and children 12 years and over2 capsules every 4 hours
    Children under 12 yearsDo not use

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

  • cough that occurs with too much phlegm(mucus)
  • cough that lasts or is chronic such as occur 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. This 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.

Other Information
  • store at 20-25 °C(68-77 °F)
  • avoid excessive heat above 40 °C (104°F)

Inactive Ingredients

FD&C Red No 40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, providone (PVP K-30), purified water, special sorbitol, titanium dioxide

Questions or Comments

Toll free 1-855-314-1850

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cough and Congestion DM,

NDC:76168-060-37  16 Softgel Liquid filled

COUGH AND CONGESTION DM 
dextromethorphan and guaifenesin capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76168-060
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOL 1000 
POVIDONE 
POVIDONE K30 
PROPYLENE GLYCOL 
FD&C RED NO. 40 
SORBITOL 
TITANIUM DIOXIDE 
Product Characteristics
ColorRED (Light) Scoreno score
ShapeOVALSize20mm
FlavorImprint Code601
Contains    
Packaging
#Item CodePackage Description
1NDC:76168-060-3716 CARTON in 1 BOTTLE
11 CAPSULE, LIQUID FILLED in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/08/2015
Labeler - Velocity Pharma (962198409)
Registrant - Velocity Pharma (962198409)

 
Velocity Pharma

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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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