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Mucus Relief Cough and Congestion DM

Medically reviewed on October 30, 2017

Dosage form: tablet
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 20mg, GUAIFENESIN 400mg
Labeler: Richmond Pharmaceuticals, Inc
NDC Code: 54738-985

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.

Guaifenesin 400 mg - DextromethorphanCaplets 20 mg Caplets

Active ingredients (in each caplet)

Dextromethorphan HBr 20 mg
Guaifenesin 400 mg

Purpose

Cough suppressant
Expectorant

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold
  • helps loosen phlegm (mucus) and 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
  • cough accompanied by too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

When using this product

do not use more than directed. 

Stop use and ask a doctor if

cough lasts more than 7 days, comes back, or occurs with 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
  • take with a full glass of water
  • adults and children 12 years of age and over: 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
  • children under 12 years: do not use

Other information
  • store at 15º-30ºC (59º-86ºF)

Inactive ingredients

Colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, stearic acid

Questions or comments?

call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Principal Display Panel

Mucus Relief Cough and Congestion DM

NDC- 54738-985-30....30 caplets

NDC- 54738-985-60....60 caplets

MUCUS RELIEF COUGH AND CONGESTION DM 
guaifenesin and dextromethorphan hbr tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54738-985
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE20 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN400 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE 
MALTODEXTRIN 
POVIDONE 
SILICON DIOXIDE 
STEARIC ACID 
MICROCRYSTALLINE CELLULOSE 
Product Characteristics
ColorwhiteScore2 pieces
ShapeOVALSize17mm
FlavorImprint CodeAP;150
Contains    
Packaging
#Item CodePackage Description
1NDC:54738-985-3030 TABLET in 1 BOTTLE
2NDC:54738-985-6060 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/01/2016
Labeler - Richmond Pharmaceuticals, Inc (043569607)
Registrant - Advance Pharmaceutical Inc. (078301063)
Establishment
NameAddressID/FEIOperations
Advance Pharmaceutical Inc.078301063manufacture(54738-985)

 
Richmond Pharmaceuticals, Inc

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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