Label: CHERACOL D COUGH FORMULA 4OZ- maximum strength cough relief syrup

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • 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 December 6, 2013

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  • 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.

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

    Keep out of reach of children.  In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

  • 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
  • PRINCIPAL DISPLAY PANEL

    label 4oz

  • PRINCIPAL DISPLAY PANEL

    carton 4oz

  • PRINCIPAL DISPLAY PANEL

    label 6oz

  • PRINCIPAL DISPLAY PANEL

    carton 6oz

  • INGREDIENTS AND APPEARANCE
    CHERACOL D  COUGH FORMULA 4OZ
    maximum strength cough relief syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:23558-5504
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    FRUCTOSE (UNII: 6YSS42VSEV)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SUCROSE (UNII: C151H8M554)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:23558-5504-01 in 1 CARTON
    1NDC:23558-5504-1118 mL in 1 BOTTLE, PLASTIC
    2NDC:23558-5504-21 in 1 CARTON
    2NDC:23558-5504-3177 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/01/2011
    Labeler - Lee Pharmaceuticals (056425432)
    Registrant - Lee Pharmaceuticals (056425432)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lee Pharmaceuticals056425432manufacture(23558-5504)
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