Label: NOVOMINSYRUP- caffeine anhydrous, meclizine hydrochloride hydrate, pyridoxine hydrochloride liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 23, 2023

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  • ACTIVE INGREDIENT

    Caffeine Anhydrous, Meclizine Hydrochloride Hydrate, Pyridoxine Hydrochloride

  • PURPOSE

    ■ throw up■ whirl ■ headache

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    ■ adult and children 15 years of age and older: 1 pack 30 minutes before boarding.

    ■ children under 15 years of age: ask a doctor

  • WARNINGS

    Ask a doctor before use if you have taking a prescription drug.

    When using this product

    ■ Do not take more than 3 pack in 24 hours

    ■ If you take an additional dose, take it after 4 hours or more

    Keep out of reach of children

  • INACTIVE INGREDIENT

    concentrated glycerin, malt syrup, high fructose 55

  • DOSAGE & ADMINISTRATION

    for oral use

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    NOVOMINSYRUP 
    caffeine anhydrous, meclizine hydrochloride hydrate, pyridoxine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72988-0034
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE20 mg  in 6 mL
    MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE25 mg  in 6 mL
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE5 mg  in 6 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72988-0034-16 mL in 1 POUCH; Type 0: Not a Combination Product01/23/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/23/2023
    Labeler - Lydia Co., Ltd. (695735569)
    Registrant - Lydia Co., Ltd. (695735569)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lydia Co., Ltd.695735569manufacture(72988-0034)
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