432 - mucus relief dm

432 - mucus relief dm
SPL v3
SPL
SPL Set ID 26a199bf-57e5-4f36-b40c-83a1187e4870
Route
oral
Published
Effective Date 2022-05-18
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: 2
Marketing Status
otc monograph drug active Since 2022-05-18

Purpose

Cough suppressant Expectorant

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg


Medication Information

Purpose

Cough suppressant

Expectorant

Directions

Adults and children 12 years 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

Other Information
  • store at 25°C (77°F) excursions between 15°-30°C (59°-86°F)
  • keep in a dry place and do not expose to heat n do not use if imprinted safety seal under cap is broken or missing
  • You may report side effects to 1-888-952-0050
Inactive Ingredients

croscarmellose sodium, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, stearic acid

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg

Principal Display Panel

Mucus Relief DB
Mucus Relief DM

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 1-888-952-0050 Monday through

Friday 9AM – 5PM

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.
Active Ingredient(s)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Pregnancy/breastfeeding

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

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

taking sedatives or tranquilizers


Structured Label Content

Purpose

Cough suppressant

Expectorant

Directions

Adults and children 12 years 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

Other Information (Other information)
  • store at 25°C (77°F) excursions between 15°-30°C (59°-86°F)
  • keep in a dry place and do not expose to heat n do not use if imprinted safety seal under cap is broken or missing
  • You may report side effects to 1-888-952-0050
Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, stearic acid

Principal Display Panel

Mucus Relief DB
Mucus Relief DM

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 1-888-952-0050 Monday through

Friday 9AM – 5PM

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

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Pregnancy/breastfeeding (Pregnancy/Breastfeeding)

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

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)

taking sedatives or tranquilizers


Advanced Ingredient Data


Raw Label Data

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