Label: CHERATUSSIN AC- codeine phosphate and guaifenesin liquid

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

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 January 24, 2019

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

  • 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
  • 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
  • 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
  • WHEN USING

    When using this product constipation may occur or be aggravated

  • 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.

  • 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

  • SPL UNCLASSIFIED SECTION

    Made in the USA
    for Qualitest Pharmaceuticals
    Huntsville, AL 35811

    Rev. 1/15 R7 8081202 1075

  • HOW SUPPLIED

    Product: 50090-0423

    NDC: 50090-0423-0 118 mL in a BOTTLE, PLASTIC

  • codeine phosphate and guaifenesin

    Label Image
  • INGREDIENTS AND APPEARANCE
    CHERATUSSIN AC 
    codeine phosphate and guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-0423(NDC:0603-1075)
    Route of AdministrationORALDEA ScheduleCV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE10 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    CARAMEL (UNII: T9D99G2B1R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-0423-0118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/28/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34109/01/1996
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-0423)