Cheracol D
FDA Label NDC 23558-5504

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Lee Pharmaceuticals for the product Cheracol D (NDC 23558-5504). 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 (5 ml teaspoonful), purpose, uses, warnings, ask a doctor before use if you have, stop use and ask a doctor if, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (5 Ml Teaspoonful)

Dextromethorphan HBr, 10mg

Guaifenesin, 100mg

Purpose

Cough suppressant

Expectorant

Uses

  • Temporarily quiets coughs due to minor throat and bronchial irritation associated with the common cold.
  • Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.

Warnings

Do not use

  • if you are now taking a perscription 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're uncertain whether your prescription drug contains MAOI, ask a doctor or pharmacist before taking this product.

Ask A Doctor Before Use If You Have

  • a persistent chronic cough such as occurs with smoking, asthma or emphysema.
  • excessive phlegm (mucus).

Stop Use And Ask A Doctor If

  • cough persists for more than one week
  • cough tends to recur or is accompanied by fever, rash or persistent headache.  A persistent cough may be a sign of a serious condition.

Directions

  • Follow dosage below or use as directed by a doctor
  • Do not exceed 6 dosages in 24 hours
  • Adults and children 12 years or age and over, 2 teaspoonfuls every 4 hours
  • Children 6 to under 12 years of age, 1 teaspoonful every 4 hours
  • Children under 6 years of age, consult a doctor

Other Information

Store from 15° - 30°C (59° - 86°F)

Inactive Ingredients

Alcohol 4.75%, benzoic acid, FD&C red #40, flavors, fructose, glycerin, propylene glycol, sodium chloride, sucrose, water.

Questions Or Comments

  • 1-800-950-5337, M-F, 9am-4pm, PST
  • Visit our website at: www.leepharmaceuticals.com

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