Label: EPHED PLUS LIQUID- ephedrine guaifenesin liquid

  • 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 April 2, 2019

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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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