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Tussin DM Cough and Chest Congestion

Dosage form: capsule, liquid filled
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 10mg, GUAIFENESIN 200mg
Labeler: PuraCap Pharmaceutical LLC
NDC Code: 51013-166

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.

Tussin DM Cough & Chest Congestion

Drug Facts

Active ingredients (in each softgel)

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 200 mg

Purposes

Cough suppressant

Expectorant

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

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 occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These 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.

Directions
  • do not take more than 12 softgels in any 24-hour period
  • this adult product is not intended for use in children under 12 years of age

age

     dose

adults and children 12 years and over

     2 softgels every 4 hours

children under 12 years

     do not use

Other information
  • store at room temperature 15-30°C (59-86°F)
  • avoid excessive heat above 40°C (104°F)

Inactive ingredients

FD&C Red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special and white edible ink

Questions or comments?

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PRINCIPAL DISPLAY PANEL

Tussin DM Cough & Chest Congestion

NDC 51013-166-08

*Compare to the active ingredients in Robitussin® Maximum Strength Cough Plus Chest Congestion DM 

TUSSIN DM COUGH AND CHEST CONGESTION 
dextromethorphan hydrobromide, guaifenesin capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51013-166
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
FD&C RED NO. 40 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
POVIDONE 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
Product Characteristics
Colorred (clear) Scoreno score
Shapecapsule (oblong) Size20mm
FlavorImprint CodePC37
Contains    
Packaging
#Item CodePackage Description
1NDC:51013-166-082 BLISTER PACK in 1 CARTON
110 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/20/2016
Labeler - PuraCap Pharmaceutical LLC (962106329)
Establishment
NameAddressID/FEIOperations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287manufacture(51013-166), analysis(51013-166)

 
PuraCap Pharmaceutical LLC

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Medically reviewed on Jul 20, 2018

Further information

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

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