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Chest Congestion Relief by Mckesson

Medically reviewed on December 18, 2016

Dosage form: tablet
Ingredients: GUAIFENESIN 400mg, DEXTROMETHORPHAN HYDROBROMIDE 20mg
Labeler: Mckesson
NDC Code: 62011-0319

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

Active Ingredient

(in each intermediate release tablet)

Guaifenesin 400 mg

Dextromethorphan HBr 20 mg

Purpose

Expectorant

Cough Suppressant

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold
  • helps loosen phelgm (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 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 of phelgm (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 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. (1-800-222-1222)

Directions
  • take with full glass of water;

    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 25° C(77°F) ; excursion permitted between 15°-30° C (59°-86°F)
  • see end flap for expiration date and lot number
  • metal content per tablet:
  • sodium 7mg, Magnesium 1mg

Inactive Ingredients

Colloidal Silicon Dioxide, Hypromellose, Microcrystalline cellulose, Magnesium stearate, Polyethylene Glycol, Stearic Acid powder, Sodium Starch Glycolate

Questions or Comments

Call 1-855-314-1850

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 62011-0319-1

CHEST CONGESTION RELIEF 
guaifenesin and dextromethorphan hbr tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62011-0319
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN400 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE20 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
HYPROMELLOSES 
CELLULOSE, MICROCRYSTALLINE 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOLS 
STEARIC ACID 
SODIUM STARCH GLYCOLATE TYPE A CORN 
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize16mm
FlavorImprint CodeTCL;280
Contains    
Packaging
#Item CodePackage Description
1NDC:62011-0319-150 CARTON in 1 BOTTLE
11 TABLET in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/25/2016
Labeler - Mckesson (177667227)

 
Mckesson

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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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