Label: FATHER JOHNS COUGH MEDICINE PLUS- nasal decongestant liquid

  • Category: HUMAN OTC DRUG LABEL

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 June 9, 2020

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  • ACTIVE INGREDIENT

    Each 30 mL (2 tablespoonfuls) contain:

    Dextromethorphan HBr, 10mg

    Phenylephrine HCl, 10mg

    Chlorpheniramine Maleate, 4mg

  • INACTIVE INGREDIENT

    Citric acid

    FD&C Red #40

    FD&C Blue #1

    Glycerin

    Purified water

    Sodium benzoate

    Sodium chloride

    Sodium citrate

    Sodium saccharin

    Sucrose

  • DOSAGE & ADMINISTRATION

    DO NOT take more than 12 tablespoonfuls in 24 hours

    Adults and Children 12 years and older: take 2 tablespoons every 4 hours

    Children under 12 years old: ask a doctor

  • INDICATIONS & USAGE

    For temporarily relief of couch and allergy symptoms, including coughing, nasal congestion, and runny nose.

  • WARNINGS

    WARNINGS: Do not excees recommended dosage

  • PURPOSE

    Cough Supressant

    Nasal Decongestant

    Anthihistamine

  • KEEP OUT OF REACH OF CHILDREN

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

  • PRINCIPAL DISPLAY PANEL

    fatherplus'

  • INGREDIENTS AND APPEARANCE
    FATHER JOHNS COUGH MEDICINE PLUS 
    nasal decongestant liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-9127
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 30 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 30 mL
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCROSE (UNII: C151H8M554)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0395-9127-941 in 1 CARTON06/17/2019
    1118 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/17/2019
    Labeler - Humco Holding Group, Inc (825672884)
    Registrant - Humco Holding Group, Inc (825672884)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humco Holding Group, Inc825672884label(0395-9127) , pack(0395-9127) , analysis(0395-9127) , manufacture(0395-9127)
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