Label: CHERATUSSIN AC- codeine phosphate and guaifenesin liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: CV
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 02/11

If you are a consumer or patient please visit this version.

  • Active ingredients (in each 5 mL = 1 tsp)

    Codeine phosphate, USP 10 mg

    Guaifenesin, USP 100 mg

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  • Purpose

    Cough suppressant

    Expectorant

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  • 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
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  • Warnings
  • 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
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  • 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
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  • WHEN USING

    When using this product constipation may occur or be aggravated

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  • 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.

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  • PREGNANCY OR BREAST FEEDING

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

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  • Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

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  • 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.

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  • 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.

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  • Inactive ingredients

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

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  • SPL UNCLASSIFIED SECTION

    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

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  • PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    CHERATUSSIN AC 
    codeine phosphate and guaifenesin liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:21695-421(NDC:0603-1075)
    Route of Administration ORAL DEA Schedule CV    
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CODEINE PHOSPHATE (CODEINE) CODEINE PHOSPHATE 10 mg  in 5 mL
    GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 100 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL  
    CARAMEL  
    CITRIC ACID  
    FD&C RED NO. 40  
    GLYCERIN  
    MENTHOL  
    WATER  
    SACCHARIN SODIUM  
    SODIUM BENZOATE  
    SORBITOL  
    Product Characteristics
    Color RED Score     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:21695-421-04 118 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 09/01/1996
    Labeler - Rebel Distributors Corp (118802834)
    Establishment
    Name Address ID/FEI Business Operations
    Rebel Distributors Corp 118802834 RELABEL, REPACK
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