Welmate Mucus Relief Dm 98ct 73581-404

Welmate Mucus Relief Dm 98ct 73581-404
SPL v2
SPL
SPL Set ID 325b5e55-ba58-312c-e063-6394a90aee55
Route
ORAL
Published
Effective Date 2025-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (60 mg) Guaifenesin (1200 mg)
Inactive Ingredients
Maltodextrin Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked) Povidone K30 Hydroxypropyl Methylcellulose Magnesium Stearate Silicon Dioxide Microcrystalline Cellulose Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: 053 Shape: oval Color: white Size: 16 mm
Marketing Status
ANDA Active Since 2025-04-01

Description

Dextromethorphan Hydrobromide 60 mg Guaifenesin 1200 mg

Purpose

Cough suppressant Expectorant


Medication Information

Purpose

Cough suppressant

Expectorant

Description

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
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.

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.

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

Questions?

call 1-866-933-6337

Active Ingredient

Dextromethorphan Hydrobromide 60 mg

Guaifenesin 1200 mg

Other Information

store at 20° - 25°C (68° - 77°F)

Inactive Ingredients

carbomer homopolymer, colloidal silicon dioxide, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone (K-30), stearic acid

Principal Display Panel


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 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.

Purpose

Cough suppressant

Expectorant

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.

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

Questions?

call 1-866-933-6337

Active Ingredient (ACTIVE INGREDIENT)

Dextromethorphan Hydrobromide 60 mg

Guaifenesin 1200 mg

Other Information (Other information)

store at 20° - 25°C (68° - 77°F)

Inactive Ingredients (Inactive ingredients)

carbomer homopolymer, colloidal silicon dioxide, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone (K-30), stearic acid

Principal Display Panel (PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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