TOA SYRUP ADULT LIQUID [MENPER DISTRIBUTORS, INC.]

TOA SYRUP ADULT LIQUID [MENPER DISTRIBUTORS, INC.]
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NDC 53145-302-84
Set ID 89cb36dd-f666-4d81-b276-3a653c8ac591
Category HUMAN OTC DRUG LABEL
Packager Menper Distributors, Inc.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • ACTIVE INGREDIENT

    Active Ingredients

    In each teaspoonful (5mL)

    Dextromethorphan HBr 10 mg…………………….Cough suppressant

    Phenylephrine HCI 5 mg………………………………Nasal decongestant

  • PURPOSE

    Purpose

    Cough suppressant

    Nasal decongestant

  • INDICATIONS & USAGE

    Uses

    • Temporarily relieves cough due to minor throat and bronchial irritation and nasal congestion as may occur with the common cold or inhaled irritants
  • WARNINGS

    Warnings

    Do not exceed recommended dosage.  A persistent cough may be a sign of a serious condition. If cough persists more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.

  • DO NOT USE

    Do not use

    • this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysema or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor
    • if you are now taking a prescription 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 do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product
    • if you have heart disease, high blood pressure, thyroid disease, diabetes, or trouble urinating due to enlargement of the prostate gland, unless directed by a doctor

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 12 years of age and over: take 2 teaspoonfuls (10 mL) every 4 hours. Do not exceed 6 doses in 24 hours.

    Children under 12 years of age: do not use.

  • INACTIVE INGREDIENT

    Inactive ingredients

    cherry flavor, FD&C red #40, FD&C yellow #6, glycerin, menthol, methylparaben, propylene glycol, propylparaben , sucrose, water.

  • QUESTIONS

    Questions?1-800-560-5223 M-F 9 AM to 4 PM Eastern

  • PRINCIPAL DISPLAY PANEL

    Toa

  • INGREDIENTS AND APPEARANCE
    TOA SYRUP ADULT 
    dextromethorphan hydrobromide, phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-302
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53145-302-841 in 1 CARTON02/21/2012
    1118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/21/2012
    Labeler - Menper Distributors, Inc. (101947166)
    Registrant - Menper Distributors, Inc. (101947166)
    Establishment
    NameAddressID/FEIBusiness Operations
    PHARMALAB ENTERPRISES, INC.174401088manufacture(53145-302)

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