432 - Mucus Relief Dm

432 - Mucus Relief Dm
SPL v3
SPL
SPL Set ID 71674a9b-89ed-43d1-aadb-b9311fdfbdf9
Route
ORAL
Published
Effective Date 2022-06-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (400 mg)
Inactive Ingredients
Croscarmellose Sodium Magnesium Stearate Maltodextrin Microcrystalline Cellulose Povidone Silicon Dioxide Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: AH432;bisect Shape: oval Color: white Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-10-31

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg

Purpose

Cough suppressant Expectorant


Medication Information

Purpose

Cough suppressant

Expectorant

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg

Use(s)
  • 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

Questions

Questions or Comments?

Call 1-888-423-0139

Directions

Adults and children 12 years of age and older: Take 1 tablet every 4 hours with a

full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.



Children under 12 years of age: 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.



Other Information
  • store between 20°-25°C (68°- 77°F)
  • keep in a dry place and do not expose to heat
  • do not use if imprinted safety seal under cap is broken or missing
  • You may report side effects to 1-888-952-0050

Active Ingredient(s)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Inactive Ingredients

croscarmellose sodium, magnesium stearate, maltodextrin, microcrystalline cellulose,

povidone, silicon dioxide, stearic acid

Pregnancy/breastfeeding

ask a health professional before use.

Principal Display Panel

Mucus Relief DM


When Using This Product
  • do not use more than directed

Ask A Doctor Before Use If
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough accompanied by too much phlegm (mucus)



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

Keep Out of Reach of Children

In case of accidental overdose, get medical help or contact a Poison Control

Center (1-800-222-1222) right away.

Ask A Doctor Or Pharmacist Before Use If

you are taking sedatives or tranquilizers


Structured Label Content

Use(s)
  • 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

Purpose

Cough suppressant

Expectorant

Questions

Questions or Comments?

Call 1-888-423-0139

Directions

Adults and children 12 years of age and older: Take 1 tablet every 4 hours with a

full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.



Children under 12 years of age: do not use

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.



Other Information (Other information)
  • store between 20°-25°C (68°- 77°F)
  • keep in a dry place and do not expose to heat
  • do not use if imprinted safety seal under cap is broken or missing
  • You may report side effects to 1-888-952-0050

Active Ingredient(s) (Active ingredient(s))

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, magnesium stearate, maltodextrin, microcrystalline cellulose,

povidone, silicon dioxide, stearic acid

Pregnancy/breastfeeding (Pregnancy/Breastfeeding)

ask a health professional before use.

Principal Display Panel

Mucus Relief DM


When Using This Product (When using this product)
  • do not use more than directed

Ask A Doctor Before Use If (Ask a doctor before use if)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough accompanied by too much phlegm (mucus)



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

Keep Out of Reach of Children (Keep out of reach of children)

In case of accidental overdose, get medical help or contact a Poison Control

Center (1-800-222-1222) right away.

Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)

you are taking sedatives or tranquilizers


Advanced Ingredient Data


Raw Label Data

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