Mucinex®dm

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (1200 mg) Dextromethorphan (60 mg)

Inactive Ingredients

Microcrystalline Cellulose Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked) D&c Yellow No. 10 Aluminum Oxide Hypromellose, Unspecified Magnesium Stearate

Identifiers & Packaging

Pill Appearance

Imprint: Mucinex;1200 Shape: oval Color: white Size: 22 mm Score: 1

Marketing Status

NDA Active Since 2012-06-26 Until 2022-06-15

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 tablet)	Purposes
Dextromethorphan HBr 60 mg	Cough suppressant
Guaifenesin 1200 mg	Expectorant

Section 55106-9

Active ingredients (in each extended-release tablet)

Dextromethorphan HBr 60 mg

Guaifenesin 1200 mg

Directions

do not crush, chew, or break extended-release 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 extended-release tablet every 12 hours; not more than 2 extended-release 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.

Questions?

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

Other Information

store at 20-25°C (68-77°F)

Inactive Ingredients

carbomer homopolymer type B; D&C yellow no. 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)

Principal Display Panel 14 Tablet Blister Pack Carton

NDC 63824-072-35

MAXIMUM STRENGTH

Mucinex®DM

1200 mg guaifenesin & 60 mg dextromethorphan HBr

extended-release tablets

EXPECTORANT & COUGH SUPPRESSANT

12

HOUR _®

Controls Cough
Thins and Loosens Mucus
Immediate and Extended Release

14

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:
- 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 tablet)	Purposes
Dextromethorphan HBr 60 mg	Cough suppressant
Guaifenesin 1200 mg	Expectorant

Section 55106-9 (55106-9)

Active ingredients (in each extended-release tablet)

Dextromethorphan HBr 60 mg

Guaifenesin 1200 mg

Directions

do not crush, chew, or break extended-release 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 extended-release tablet every 12 hours; not more than 2 extended-release 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.

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; D&C yellow no. 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)

Principal Display Panel 14 Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 14 Tablet Blister Pack Carton)

NDC 63824-072-35

MAXIMUM STRENGTH

Mucinex®DM

1200 mg guaifenesin & 60 mg dextromethorphan HBr

extended-release tablets

EXPECTORANT & COUGH SUPPRESSANT

12

HOUR _®

Controls Cough
Thins and Loosens Mucus
Immediate and Extended Release

14

EXTENDED-RELEASE TABLETS

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

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Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information