yyba (as pld) - welmate mucus relief - dm (maximum strength (73581-404)

yyba (as pld) - welmate mucus relief - dm (maximum strength (73581-404)
SPL v2
SPL
SPL Set ID fc8c9341-6d6f-d194-e053-6294a90ac891
Route
oral
Published
Effective Date 2023-05-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dextromethorphan (60 mg) guaifenesin (1200 mg)
Inactive Ingredients
silicon dioxide starch, corn povidone, unspecified hypromellose, unspecified magnesium stearate microcrystalline cellulose

Identifiers & Packaging

Pill Appearance
Imprint: X;63 Shape: oval Color: white Size: 23 mm Score: 1
Marketing Status
anda active Since 2023-05-25

Purpose

Cough suppressant Expectorant

Description

Dextromethorphan Hydrobromide 60 mg Guaifenesin 1200 mg


Medication Information

Warnings

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.

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)

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.

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

Active Ingredient

Dextromethorphan Hydrobromide 60 mg

Guaifenesin 1200 mg

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
Purpose

Cough suppressant

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 tablet every 12 hours; not more than 2 tablets in 24 hours
  • children under 12 years of age: do not use
Other Information
  • store at 20° - 25°C (68° - 77°F)
Inactive Ingredients

colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize)

Description

Dextromethorphan Hydrobromide 60 mg Guaifenesin 1200 mg

Questions?

call 1-866-933-6337

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 51945-4


Structured Label Content

Warnings

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.

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)

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.

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

Active Ingredient (Active ingredient (in each tablet))

Dextromethorphan Hydrobromide 60 mg

Guaifenesin 1200 mg

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
Purpose

Cough suppressant

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 tablet every 12 hours; not more than 2 tablets in 24 hours
  • children under 12 years of age: do not use
Other Information (Other information)
  • store at 20° - 25°C (68° - 77°F)
Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize)

Questions?

call 1-866-933-6337

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 51945-4 (51945-4)


Advanced Ingredient Data


Raw Label Data

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