MUCUS RELIEF DM

MUCUS RELIEF DM

Drug Labeling and Warnings

Drug Details

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MUCUS RELIEF DM- guaifenesin and dextromethorphan hydrobromide capsule, liquid filled 
Spirit Pharmaceuticals LLC

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.

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MUCUS RELIEF DM

Drug Facts

Active ingredient (in each softgel)Purposes
Guaifenesin 400mgExpectorant
Dextromethorphan HBr 20mgCough Suppressant

Uses

  • helps loosen phlegm (mucus)
  • helps 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 Doctor before use if you have

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

When using this product

  • do not exceed recommended dosage
  • do not use for more than 7 days

Stop use and ask a doctor if

  • cough lasts for more than 7 days, recurs, 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 accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and older:

  • Take with a full glass of water.
  • Take 1 softgel every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.
  • Children under 12 years of age: do not use

Other information

  • store at 25°C (77°F) excursions between 15° - 30°C (59° - 86°F)
  • keep in a dry place and do not expose to heat
  • you may report side effects to 1-888-333-9792

Inactive Ingredients

 gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Questions or comments?

1-888-333-9792

PRINCIPAL DISPLAY PANEL

Mucus Relief DM

COUGH

GUAIFENESIN 400 mg/EXPECTORANT
DEXTROMETHORPHAN HBr 20 mg/COUGH SUPPRESSANT

DISSOLVES QUICKLY

Controls cough
Thins & loosens mucus

image description

image description

MUCUS RELIEF DM 
guaifenesin and dextromethorphan hydrobromide capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68210-1930
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE K30 (UNII: U725QWY32X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColoryellowScoreno score
ShapeOVAL (OBLONG) Size20mm
FlavorImprint Code 440
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68210-1930-44 in 1 CARTON03/12/2020
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC: 68210-1930-11 in 1 CARTON03/12/2020
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/12/2020
Labeler - Spirit Pharmaceuticals LLC (179621011)
Registrant - Spirit Pharmaceuticals LLC (179621011)
Establishment
NameAddressID/FEIBusiness Operations
MEDGEL PVT LTD677385498manufacture(68210-1930)

Revised: 3/2020
 
Spirit Pharmaceuticals LLC


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