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Mucinex D Maximum Strength Prescribing Information

Package insert / product label
Generic name: guaifenesin and pseudoephedrine hydrochloride
Dosage form: tablet, extended release

Medically reviewed by Drugs.com. Last updated on Aug 24, 2023.

Drug Facts

Active ingredients (in each extended-release bi-layer tablet)Purposes
Guaifenesin 1200 mgExpectorant
Pseudoephedrine HCl 120 mgNasal Decongestant

Indications and Usage for Mucinex D Maximum Strength

  • 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.

Mucinex D Maximum Strength Dosage and Administration

  • 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: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
  • children under 12 years of age: do not use

Storage and Handling

  • 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.

Dist. by: RB Health (US)
Parsippany, NJ 07054-0224

Made in England

PRINCIPAL DISPLAY PANEL - 24 Tablet Blister Pack Carton

MAXIMUM STRENGTH

NDC 63824-041-24

Mucinex®D
1200 mg guaifenesin & 120 mg pseudoephedrine HCl
extended-release bi-layer tablets

EXPECTORANT
& NASAL DECONGESTANT

12
HOUR®

✔
Clears Nasal/Sinus Congestion
✔
Thins and Loosens Mucus
✔
Immediate and Extended Release

24
EXTENDED-RELEASE
BI-LAYER TABLETS

Principal Display Panel - 24 Tablet Blister Pack Carton
MUCINEX D MAXIMUM STRENGTH
guaifenesin and pseudoephedrine hydrochloride tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-041
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin1200 mg
Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F) Pseudoephedrine Hydrochloride120 mg
Inactive Ingredients
Ingredient NameStrength
carbomer homopolymer type B (allyl pentaerythritol crosslinked) (UNII: HHT01ZNK31)
FD&C yellow NO. 6 (UNII: H77VEI93A8)
aluminum oxide (UNII: LMI26O6933)
hypromellose, unspecified (UNII: 3NXW29V3WO)
magnesium stearate (UNII: 70097M6I30)
microcrystalline cellulose (UNII: OP1R32D61U)
Product Characteristics
ColorORANGE, WHITEScoreno score
ShapeOVALSize22mm
FlavorImprint CodeMucinex;1200
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-041-242 in 1 CARTON06/26/2012
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:63824-041-7124 in 1 CARTON06/26/201207/10/2017
21 in 1 POUCH; Type 0: Not a Combination Product
3NDC:63824-041-363 in 1 CARTON06/26/201209/12/2017
312 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:63824-041-121 in 1 CARTON01/01/2020
412 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02158506/26/2012
Labeler - RB Health (US) LLC (081049410)

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