Topcare Mucus Dm Tablet, Extended Release
FDA Label NDC 36800-592

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topcare Mucus Dm (NDC 36800-592). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients (in each extended-release tablet), purposes, uses, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each Extended-Release Tablet)

Dextromethorphan HBr 60 mg

Guaifenesin 1200 mg

Purposes

Cough suppressant

Expectorant

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

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.

Keep Out Of Reach Of Children.

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

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

  • each tablet contains: magnesium 25 mg
  • do not use if printed foil under cap is broken or missing
  • store between 20-25°C (68-77°F)

Inactive Ingredients

carbomer homopolymer type B, copovidone, D&C yellow #10 aluminum lake, hypromellose, magnesium hydroxide, magnesium stearate, microcrystalline cellulose, silicon dioxide

Questions Or Comments?

1-888-423-0139

Package/Label Principal Display Panel

COMPARE TO MAXIMUM STRENGTH MUCINEX® DM ACTIVE INGREDIENTS

MAXIMUM STRENGTH

Mucus DM

GUAIFENESIN 1200 mg & DEXTROMETHORPHAN HYDROBROMIDE 60 mg

EXTENDED-RELEASE TABLETS

EXPECTORANT/COUGH SUPPRESSANT

12 HOUR

Controls Cough

Thins and Loosens Mucus

OUR PHARMACISTS RECOMMEND

14 EXTENDED-RELEASE TABLETS

actual size

81288-mucus-dm.jpg (81288 Mucus Dm)

81288-mucus-dm.jpg (81288 Mucus Dm)

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