mucus relief dm softgels

mucus relief dm softgels
SPL v5
SPL
SPL Set ID 5e1aff7d-41c0-4b39-8b0c-1a5aadda612d
Route
oral
Published
Effective Date 2021-04-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
guaifenesin (400 mg) dextromethorphan (20 mg)
Inactive Ingredients
gelatin glycerin polyethylene glycol 400 povidone k30 propylene glycol water sorbitol sorbitan titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 440;901 Shape: oval Color: yellow Size: 20 mm Score: 1
Marketing Status
otc monograph drug active Since 2021-04-29

Description

Drug Facts


Medication Information

Uses
  • temporarily relieves cough due to minor throat and

    bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial

    secretions to rid the bronchial passageways of

    bothersome mucus and make coughs more productive
Directions
  • do not exceed 6 doses in 24 hours
  • take with a full glass of water
  • adults and children 12 years of age and over: take 1 softgel every 4 hours
  • children under 12 years of age: do not use
Other Information
  • store at 25°C (77°F); excursions permitted between 15°- 30°C (59° - 86°F)
  • keep in a dry place and do not expose to heat
Inactive Ingredients

gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Description

Drug Facts

Principal Display Panel

Mucus relief DM

Dextromethorphan HBr 20 mg- cough suppressant

Guaifenesin 400 mg - expectorant



• Controls Cough • Thins & Loosens Mucus



10 Softgels

Section 42229-5

Drug Facts

Section 50565-1

Keep Out of Reach of Children In case of accidental 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 ingredient (in each softgel) Purposes
Guaifenesin 400mg Expectorant
Dextromethorphan HBr 20mg Cough Suppressant
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.
Questions Or Comments?

1-888-333-9792

When Using This Product
  • do not exceed recommended dosage
  • do not use for more than 7 days
Stop Use and Ask A Doctor If
  • cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
Ask Doctor Before Use If You Have
  • cough accompanied by excessive phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema

Structured Label Content

Uses
  • temporarily relieves cough due to minor throat and

    bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial

    secretions to rid the bronchial passageways of

    bothersome mucus and make coughs more productive
Directions
  • do not exceed 6 doses in 24 hours
  • take with a full glass of water
  • adults and children 12 years of age and over: take 1 softgel every 4 hours
  • children under 12 years of age: do not use
Other Information (Other information)
  • store at 25°C (77°F); excursions permitted between 15°- 30°C (59° - 86°F)
  • keep in a dry place and do not expose to heat
Inactive Ingredients

gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Mucus relief DM

Dextromethorphan HBr 20 mg- cough suppressant

Guaifenesin 400 mg - expectorant



• Controls Cough • Thins & Loosens Mucus



10 Softgels

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep Out of Reach of Children In case of accidental 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 ingredient (in each softgel) Purposes
Guaifenesin 400mg Expectorant
Dextromethorphan HBr 20mg Cough Suppressant
Do Not Use (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.
Questions Or Comments? (Questions or comments?)

1-888-333-9792

When Using This Product (When using this product)
  • do not exceed recommended dosage
  • do not use for more than 7 days
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
Ask Doctor Before Use If You Have (Ask Doctor before use if you have)
  • cough accompanied by excessive phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema

Advanced Ingredient Data


Raw Label Data

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