Label: LAXATIVES RUBILAX- psyllium huskpowder granule

  • NDC Code(s): 72988-0010-1, 72988-0010-2
  • Packager: Lydia Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated December 16, 2023

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  • ACTIVE INGREDIENT

    psyllium husk powder, sennae fructus powder

  • INACTIVE INGREDIENT

    lactose monohydrate, acacia, corn starch, carboxymethylcellulose calcium, l-menthol

  • PURPOSE

    constipation

    relieving the following symptoms of constipation: loss of appetite, abdominal distension, intestinal fermentation, hemorrhoids

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    adults take intake does of 3.5g twice a day morning and evening on an empty stomach, however, taking the minimum amount of the first time and watching the shape and condition of the stomach gradually increases or decreases

  • WARNINGS

    do not administer to the following patients,

    the product contains lactose, patients with rare hereditary problems of galactose intolerance, the lapp deficiency or glucose-galactose malabsorption should not take this medicine

  • DOSAGE & ADMINISTRATION

    for oral use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    LAXATIVES RUBILAX 
    psyllium huskpowder granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72988-0010
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK2168 mg  in 3.5 g
    SENNA PODS (UNII: S8SJ19N2NX) (SENNA PODS - UNII:S8SJ19N2NX) SENNA PODS496 mg  in 3.5 g
    Inactive Ingredients
    Ingredient NameStrength
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72988-0010-230 in 1 POUCH04/22/2019
    1NDC:72988-0010-13.5 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/22/2019
    Labeler - Lydia Co., Ltd. (695735569)
    Registrant - Lydia Co., Ltd. (695735569)
    Establishment
    NameAddressID/FEIBusiness Operations
    I World Pharmaceutical Co., Ltd.688222857manufacture(72988-0010)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lydia Co., Ltd.695735569label(72988-0010)
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