Chest Congestion Relief
FDA Label NDC 62011-0319

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mckesson for the product Chest Congestion Relief (NDC 62011-0319). 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, purpose, uses, warnings, keep out of reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

(in each intermediate release tablet)

Guaifenesin 400 mg

Dextromethorphan HBr 20 mg

Purpose

Expectorant

Cough Suppressant

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold
  • helps loosen phelgm (mucus) and thin bronchial secretions to make coughs more productive

Warnings

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 your prescription drug contains an MAOI ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • cough accompanied by too much of phelgm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • when using this product do not use more than directed

    • Stop use and ask 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 condition.

    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

  • take with full glass of water;

    1 tablet every 4 hours

  • do not take more than 6 tablets in 24 hours
  • children under 12 years: do not use

Other Information

  • store at 25° C(77°F) ; excursion permitted between 15°-30° C (59°-86°F)
  • see end flap for expiration date and lot number
  • metal content per tablet:
  • sodium 7mg, Magnesium 1mg

Inactive Ingredients

Colloidal Silicon Dioxide, Hypromellose, Microcrystalline cellulose, Magnesium stearate, Polyethylene Glycol, Stearic Acid powder, Sodium Starch Glycolate

Questions Or Comments

Call 1-855-314-1850

Package Label.Principal Display Panel

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NDC 62011-0319-1

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