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Mucinex D by Reckitt Benckiser LLC

Dosage form: tablet, extended release
Ingredients: Guaifenesin 600mg, Pseudoephedrine Hydrochloride 60mg
Labeler: Reckitt Benckiser LLC
NDC Code: 63824-057

Mucinex®D

Drug Facts

Active ingredients (in each extended-release bi-layer tablet)Purpose
Guaifenesin 600 mgExpectorant
Pseudoephedrine HCl 60 mgNasal Decongestant

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves nasal congestion due to:
    • common cold
    • hay fever
    • upper respiratory allergies
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
  • temporarily relieves sinus congestion and pressure

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

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough accompanied by too much phlegm (mucus)

When using this product

  • do not use more than directed

Stop use and ask a doctor if

  • you get nervous, dizzy, or sleepless
  • symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness.

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 crush, chew, or break tablet
  • take with a full glass of water
  • this product can be administered without regard for timing of meals
  • adults and children 12 years and older: 2 tablets every 12 hours; not more than 4 tablets in 24 hours
  • children under 12 years of age: do not use

Other information
  • tamper evident: do not use if carton is open or if printed seal on blister is broken or missing
  • store at 20-25°C (68-77°F)

Inactive ingredients

Carbomer homopolymer type B; FD&C yellow #6 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Questions?

1-866-MUCINEX (1-866-682-4639) You may also report side effects to this phone number.

Distributed by:
Reckitt Benckiser
Parsippany, NJ 07054-0224
© 2012 RB

PRINCIPAL DISPLAY PANEL - 18 Tablet Carton

NDC 63824-057-18

Mucinex®D
600 mg guaifenesin & 60 mg pseudoephedrine HCl
extended-release bi-layer tablets

EXPECTORANT & NASAL DECONGESTANT

12
HOUR

Clears Nasal/Sinus Congestion
Thins And Loosens Mucus

18 extended-release bi-layer tablets

MUCINEX D 
guaifenesin and pseudoephedrine hydrochloride tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-057
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (Guaifenesin) Guaifenesin600 mg
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride60 mg
Inactive Ingredients
Ingredient NameStrength
carbomer homopolymer type B (allyl pentaerythritol crosslinked) 
FD&C yellow NO. 6 
aluminum oxide 
hypromelloses 
magnesium stearate 
cellulose, microcrystalline 
Product Characteristics
ColorORANGE, WHITEScoreno score
ShapeOVALSize16mm
FlavorImprint CodeMucinex;600
Contains    
Packaging
#Item CodePackage Description
1NDC:63824-057-181 BLISTER PACK in 1 CARTON
118 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
2NDC:63824-057-364 BLISTER PACK in 1 CARTON
29 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02158506/26/2012
Labeler - Reckitt Benckiser LLC (094405024)

 
Reckitt Benckiser LLC

Further information

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

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