EPHED PLUS LIQUID (EPHEDRINE GUAIFENESIN) LIQUID [DICKEY CONSUMER PRODUCTS DBA DMD]

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EPHED PLUS LIQUID (EPHEDRINE GUAIFENESIN) LIQUID [DICKEY CONSUMER PRODUCTS DBA DMD]
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NDC 65193-180-57
Set ID e12ffea3-29f9-4748-92ed-dfcf91f5a0c2
Category HUMAN OTC DRUG LABEL
Packager Dickey Consumer Products DBA DMD
Generic Name
Product Class alpha-Adrenergic Agonist, beta-Adrenergic Agonist
Product Number
Application Number PART341
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  • WARNINGS

    Warnings

  • PURPOSE

    Purpose: Bronchodilator, Expectorant

  • INDICATIONS & USAGE

    Uses  for temporary relief of mild symptoms of intermittent asthma:  wheezing
    tightness of chest , shortness of breath , helps loosen phlegm (mucus) and thin
    bronchial secretions to rid bronchial passageways of bothersome mucus, and to make
    coughs more productive

  • 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.

  • PREGNANCY OR BREAST FEEDING

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

  • DOSAGE & ADMINISTRATION

    Directions do not take more than directed

    ­ adults and children 12 years of age and over: take 1

    bottle every 4 hours as needed. Do not take more than

    6 bottles in 24 hours ­ children under 12 years of age:

    do not use

  • INACTIVE INGREDIENT

    Inactive ingredients Blue #1, Citric Acid,
    Filtered Water, Malic Acid, Natural and Artificial Flavors,
    Potassium Sorbate, Propylene Glycol, Sodium

  • ACTIVE INGREDIENT

    Ephedrine HCI 25 mg, Bronchodilator
    Guaifenesin 400 mg, Expectorant

  • PRINCIPAL DISPLAY PANEL

    Ephed Plus Asthma 2oz grape

  • INGREDIENTS AND APPEARANCE
    EPHED PLUS LIQUID 
    ephedrine guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65193-180
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EPHEDRINE HYDROCHLORIDE (UNII: NLJ6390P1Z) (EPHEDRINE - UNII:GN83C131XS) EPHEDRINE HYDROCHLORIDE25 mg  in 60 mL
    guaifenesin (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) guaifenesin400 mg  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    MALIC ACID (UNII: 817L1N4CKP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    Colorpurple (purple) Score    
    ShapeSize
    FlavorgrapeImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65193-180-5760 mL in 1 BOTTLE; Type 0: Not a Combination Product11/10/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/10/2017
    Labeler - Dickey Consumer Products DBA DMD (835974056)
    Registrant - Dickey Consumer Products DBA DMD (835974056)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultraseal Corporation085752004pack(65193-180)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULTRAtab Laboratories, Inc.151051757manufacture(65193-180)
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