Mucinex® D

Mucinex® D
SPL v11
SPL
SPL Set ID d9264518-2f2c-498f-b733-6f3397336a01
Route
ORAL
Published
Effective Date 2022-01-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (1200 mg) Pseudoephedrine (120 mg)
Inactive Ingredients
Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked) Fd&c Yellow No. 6 Aluminum Oxide Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance
Imprint: Mucinex;1200 Shape: oval Color: orange Color: white Size: 22 mm Score: 1
Marketing Status
NDA Active Since 2012-06-26 Until 2022-12-31

Description

Drug Facts


Medication Information

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50570-1

Do not useif 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.

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

Section 55105-1
Active ingredients (in each extended-release tablet) Purposes
Guaifenesin 1200 mg Expectorant
Pseudoephedrine HCl 120 mg Nasal Decongestant
Section 55106-9

Active ingredients (in each extended-release tablet) Purposes

Guaifenesin 1200 mg Expectorant

Pseudoephedrine HCl 120 mg Nasal Decongestant

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

1-866-MUCINEX (1-866-682-4639)

Other Information
  • store at 20-25°C (68-77°F)
Inactive Ingredients

carbomer homopolymer type B; FD&C yellow no. 6 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

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.
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)
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 TABLETS


Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50570-1 (50570-1)

Do not useif 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.

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Section 55105-1 (55105-1)
Active ingredients (in each extended-release tablet) Purposes
Guaifenesin 1200 mg Expectorant
Pseudoephedrine HCl 120 mg Nasal Decongestant
Section 55106-9 (55106-9)

Active ingredients (in each extended-release tablet) Purposes

Guaifenesin 1200 mg Expectorant

Pseudoephedrine HCl 120 mg Nasal Decongestant

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

1-866-MUCINEX (1-866-682-4639)

Other Information (Other information)
  • store at 20-25°C (68-77°F)
Inactive Ingredients (Inactive ingredients)

carbomer homopolymer type B; FD&C yellow no. 6 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

When Using This Product (When using this product)
  • do not use more than directed
Stop Use and Ask A Doctor If (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.
Ask A Doctor Before Use If You Have (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)
Principal Display Panel 24 Tablet Blister Pack Carton (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 TABLETS


Advanced Ingredient Data


Raw Label Data

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