Mucinex ®

Mucinex ®
SPL v8
SPL
SPL Set ID c274b05c-8f05-4980-9a93-77affb322e57
Route
ORAL
Published
Effective Date 2022-05-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (600 mg) Dextromethorphan (30 mg)
Inactive Ingredients
Sodium Starch Glycolate Type A Potato Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked) D&c Yellow No. 10 Aluminum Oxide Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance
Imprint: Mucinex;600 Shape: oval Color: white Size: 16 mm Score: 1
Marketing Status
NDA Active Since 2010-05-10

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:
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help you get to sleep
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 53414-9

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

Section 55105-1
Active ingredients

(in each extended-release bi-layer tablet)
Purpose
Dextromethorphan HBr 30 mg Cough suppressant
Guaifenesin 600 mg Expectorant
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 or 2 tablets every 12 hours; not more than 4 tablets in 24 hours
  • children under 12 years of age: do not use
Do Not Use
  • for children under 12 years of age
  • 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.
Mucinex ®

Mucinex® DM

600 mg guaifenesin & 30 mg dextromethorphan HBr

extended-release bi-layer tablets

EXPECTORANT & COUGH SUPPRESSANT

12 HOUR

[caplet image]

  • Controls Cough
  • Thins And Loosens Mucus

2 EXTENDED-RELEASE BI-LAYER TABLETS

[Lil' Drug Store® logo]

Questions?

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

You may also report side effects to this phone number.

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

carbomer homopolymer type B; D&C yellow #10 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
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.
Ask A Doctor Before Use If You Have
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough accompanied by too much phlegm (mucus)

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:
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help you get to sleep
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 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 bi-layer tablet)
Purpose
Dextromethorphan HBr 30 mg Cough suppressant
Guaifenesin 600 mg Expectorant
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 or 2 tablets every 12 hours; not more than 4 tablets in 24 hours
  • children under 12 years of age: do not use
Do Not Use (Do not use)
  • for children under 12 years of age
  • 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.
Mucinex ®

Mucinex® DM

600 mg guaifenesin & 30 mg dextromethorphan HBr

extended-release bi-layer tablets

EXPECTORANT & COUGH SUPPRESSANT

12 HOUR

[caplet image]

  • Controls Cough
  • Thins And Loosens Mucus

2 EXTENDED-RELEASE BI-LAYER TABLETS

[Lil' Drug Store® logo]

Questions?

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

You may also report side effects to this phone number.

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

carbomer homopolymer type B; D&C yellow #10 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)
  • cough lasts more than 7 days, comes back, or occurs with 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)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough accompanied by too much phlegm (mucus)

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)