Mucus Relief Tablet
FDA Label NDC 37835-408

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bi-mart for the product Mucus Relief (NDC 37835-408). 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 ingredient (in each extended-release bi-layer tablet), purpose, uses, warnings, otc - pregnancy or breast feeding, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Extended-Release Bi-Layer Tablet)

Guaifenesin 600 mg

Purpose

Expectorant

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageway of bothersome mucus and make coughs more productive

Warnings

Do not use

  • for children under 12 years of age

    • 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 excessive 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.

Otc - Pregnancy Or Breast Feeding

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

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 of age and over: 1 or 2 tablet every 12 hours. Do not exceed 4 tablets in 24 hours.
  • children under 12 years of age: do not use

Other Information

  • store at 20-25°C (68-77°F)
  • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Inactive Ingredients

carbomer homopolymer type B, hypromellos, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.

Questions?

call toll-free 1-844-912-4012

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