Mucus Relief Er Dm

Mucus Relief Er Dm
SPL v3
SPL
SPL Set ID 33baf963-b29c-4d89-8423-7d91000acae8
Route
ORAL
Published
Effective Date 2020-02-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (600 mg) Dextromethorphan (30 mg)
Inactive Ingredients
Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked) Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Sodium Starch Glycolate Type A Potato

Identifiers & Packaging

Pill Appearance
Imprint: xeunciM;600 Shape: oval Color: white Size: 16 mm Score: 1
Marketing Status
NDA Active Since 2019-05-30

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 (1-800-222-1222).

Section 50566-9

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.
Section 50567-7

When using this product

  • do not use more than directed
Section 50569-3

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)
Section 50570-1

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.
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 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
Questions?

1-800-632-6900

You may also report side effects to this phone number.

Other Information
  • Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing.
  • store between 20-25°C (68-77°F)
Inactive Ingredients

carbomer homopolymer type B; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Principal Display Panel 20 Tablet Blister Pack Carton

COMPARE TO the active ingredients of

MUCINEX® DM*

See back panel

NDC 30142-991-20

Kroger®

OUR PHARMACIST RECOMMENDED

Mucus Relief

ER DM

Guaifenesin 600 mg &

Dextromethorphan HBr 30 mg

Extended-Release

Tablets

EXPECTORANT &

COUGH SUPPRESSANT

12

HOUR

  • Controls Cough
  • Thins and Loosens Mucus
  • Immediate & Extended Release

actual

size

20 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 (1-800-222-1222).

Section 50566-9 (50566-9)

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.
Section 50567-7 (50567-7)

When using this product

  • do not use more than directed
Section 50569-3 (50569-3)

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)
Section 50570-1 (50570-1)

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.
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 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
Questions?

1-800-632-6900

You may also report side effects to this phone number.

Other Information (Other information)
  • Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing.
  • store between 20-25°C (68-77°F)
Inactive Ingredients (Inactive ingredients)

carbomer homopolymer type B; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Principal Display Panel 20 Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 20 Tablet Blister Pack Carton)

COMPARE TO the active ingredients of

MUCINEX® DM*

See back panel

NDC 30142-991-20

Kroger®

OUR PHARMACIST RECOMMENDED

Mucus Relief

ER DM

Guaifenesin 600 mg &

Dextromethorphan HBr 30 mg

Extended-Release

Tablets

EXPECTORANT &

COUGH SUPPRESSANT

12

HOUR

  • Controls Cough
  • Thins and Loosens Mucus
  • Immediate & Extended Release

actual

size

20 EXTENDED-RELEASE

TABLETS


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)