Cheratussin Ac
FDA Label NDC 21695-421

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rebel Distributors Corp for the product Cheratussin Ac (NDC 21695-421). 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 5 ml = 1 tsp), purpose, uses, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, otc - pregnancy 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 5 Ml = 1 Tsp)

Codeine phosphate, USP 10 mg

Guaifenesin, USP 100 mg

Purpose

Cough suppressant

Expectorant

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • calms the cough control center and relieves coughing

Otc - Do Not Use

Do not use

  • in a child under 2 years of age
  • if you or your child has a chronic pulmonary disease or shortness of breath
  • if your child is taking other drugs, unless directed by a doctor

Otc - Ask Doctor

Ask a doctor before use if you have

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

Otc - When Using

When using this product constipation may occur or be aggravated

Otc - Stop Use

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

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 right away.

Directions

  • take every 4 hours
  • do not take more than 6 doses in any 24-hour period

    • adults and children 12 years and over

    take 10 mL (2 tsp)

    children 6 years to under 12 years

    take 5 mL (1 tsp)

    children 2 years to under 6 years

    consult a doctor

    children under 2 years

    do not use

    Attention: A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. Giving a higher dose than recommended by a doctor could result in serious side effects for your child.

Other Information

store at 15° to 30°C (59° to 86°F)

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive Ingredients

alcohol, caramel, citric acid, FD&C red #40, flavor, glycerin, menthol racemic, purified water, saccharin sodium, sodium benzoate, sorbitol solution

Other

Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811

Rev. 11/09 R6 8081202 1075

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

* Please review the disclaimer below.