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Mucinex D

Pronunciation

Generic Name: guaifenesin and pseudoephedrine hydrochloride
Dosage Form: tablet, extended release

Mucinex®D

Drug Facts

Active ingredients (in each extended-release bi-layer tablet) Purpose
Guaifenesin 600 mg Expectorant
Pseudoephedrine HCl 60 mg Nasal 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.

Slideshow: OTC Medication Use In Pregnancy: Wise or Worrisome?

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 934P, NF; FD&C yellow #6 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Distributed by:
Reckitt Benckiser Inc.
Parsippany, NJ 07054-0224
©RBI 2009

PRINCIPAL DISPLAY PANEL - 600 mg Carton

NDC 63824-057-18

Mucinex®D

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

EXPECTORANT & NASAL DECONGESTANT

12 HOUR

NEW LOOK-
SAME RELIEF

Thins And Loosens Mucus

Clears Nasal/Sinus Congestion

18 EXTENDED-RELEASE BI-LAYER TABLETS

Mucinex D 
guaifenesin and pseudoephedrine hydrochloride tablet, extended release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-057
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Guaifenesin (Guaifenesin) Guaifenesin 600 mg
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride 60 mg
Product Characteristics
Color ORANGE, WHITE Score no score
Shape OVAL Size 16mm
Flavor Imprint Code Mucinex;600
Contains         
Packaging
# Item Code Package Description
1 NDC:63824-057-18 2 BLISTER PACK (BLISTER PACK) in 1 CARTON
1 9 TABLET, EXTENDED RELEASE (TABLET) in 1 BLISTER PACK
2 NDC:63824-057-36 4 BLISTER PACK (BLISTER PACK) in 1 CARTON
2 9 TABLET, EXTENDED RELEASE (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021585 04/17/2009
Labeler - Reckitt Benckiser, Inc. (094405024)
Revised: 12/2009
 
Reckitt Benckiser, Inc.



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