Chest Congestion Relief Liquid
FDA Label NDC 0536-1313

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rugby Laboratories for the product Chest Congestion Relief (NDC 0536-1313). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient

Dextromethorphan HBr, 10 mg

Guaifenesin 100 mg

Otc - Purpose

Purpose

Cough suppressant

Expectorant

Indications & Usage

Uses

  • temporarily relieves cough due to minor thoat and bronchial irritation
  • helps loosen phlegm (mucus)
  • helps thin bronchial secretions to make coughs more productive

Warnings

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, 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. 

Do not use ifyou have ever had an allergic reaction to any of the ingredients in this product.

Ask a doctor before use if you have

  • a cough with too much phlegm (mucus)
  • a cough that lasts or is chronic such as occurs with smoking asthma, chronic bronchitis or emphysema.

    • Stop use and ask a doctor if cough lasts more than 7 days, comes back or is accompanied by fever, rash, or headache that lasts. These could be signs of a serious condition. 

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

Directions

  • take every 4 hours as needed, or as directed by a doctor
  • do not take moer than 6 doses in 24 hours
  • do not exceed recommended dose
    •  Adults and children 12 years and over 2 teasponsfuls (10 mL)
     Children under 12 years do not use

Inactive Ingredient

Inactive ingredients: Cherry flavor, citric acid, FD&C Red #40, menthol, methylparaben, propylene glycol, propylparaben, water, sodium citrate, sucralose, sucrose.

Otc - Questions

1-800-645-2158

Package Label.Principal Display Panel

Image Description (Chestreldm)

Image Description (Chestreldm)

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