1. Home
  2. Labeler Index
  3. Rebel Distributors Corp
  4. 21695-421
  5. Label Information: Cheratussin Ac

FDA Label for Cheratussin Ac

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH 5 ML = 1 TSP)
    2. PURPOSE
    3. USES
    4. OTC - DO NOT USE
    5. OTC - ASK DOCTOR
    6. OTC - WHEN USING
    7. OTC - STOP USE
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. OTHER

Cheratussin Ac Product Label

The following document was submitted to the FDA by the labeler of this product Rebel Distributors Corp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.