Label: GALEO- dihydroxydibutylether liquid

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

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Drug Label Information

Updated February 16, 2017

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  • Active Ingredients

    Dihydroxydibutylether 5g

  • Purpose

    Digestive aid

  • Keep out of reach of children

    • In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Uses

    Helps relieve symptoms associated with indigestion: such as bloating, nausea, digestive discomfort, eructation.

  • Warnings

    For oral use only

    Do not use if you have
    • glaucoma
    • difficulty in urination, prostate disease ( risk of ischuria)
    • billiary atresia
    • cholelithiasis
    • liver disease
    • previously experienced sensitivity to this medication

    Ask a doctor, dentist, or pharmacist before use if the user takes
    • other medication
    • reserpine derivatives
    • cholagogue

    Stop use and ask a doctor if
    • there is no remission of symptoms after several dosages for 2 weeks.

    Store at cool temperature and dry place with a closed container. Avoid direct sunlight. - Store in a container other than its original container is equivalent to misuse. In order to prevent the reduction of drug efficacy, keep the product in its original container for storage.

    This product contains Sodium Benzoate: it may cause minor irritation on skin, eye, and mucous membrane.

  • Directions

    • do not take more than the recommended dose
    • adults: take 0.5-1g per session, 1-3 times per day, before meal.

  • Inactive Ingredients

    Sodium Benzoate, D-Sorbitol Solution 70%, Anhydrous Citric Acid, Purified Water

  • Galeo

    galeo label

  • INGREDIENTS AND APPEARANCE
    GALEO 
    dihydroxydibutylether liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58354-100
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    4,4'-OXYDI-2-BUTANOL (UNII: CR6X2Y7NRR) (4,4'-OXYDI-2-BUTANOL - UNII:CR6X2Y7NRR) 4,4'-OXYDI-2-BUTANOL5 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SORBITOL (UNII: 506T60A25R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58354-100-021 in 1 PACKAGE02/28/2017
    1NDC:58354-100-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/28/2017
    Labeler - Cho-A Pharm.Co.,Ltd. (688056831)
    Registrant - Cho-A Pharm.Co.,Ltd. (688056831)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cho-A Pharm.Co.,Ltd.688056831manufacture(58354-100)
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