Label: SORBITOL solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 January 17, 2018

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  • Active Ingredients

    Active Ingredients . . . . . . . .Purpose
    Sorbitol 70% . . . . . . . . . . . . .Laxative

  • Uses

    For occasional relief of constipation.

  • Directions

    For adults or children 12 years or over. Use 2-4 TBSP (30-60ml)
    daily or as directed by a Physician.

  • DOSAGE & ADMINISTRATION

    Use 2-4 TBSP (30-60ml)
    daily or as directed by a Physician.

  • Warnings

    This product does not contain a child resistant cap. Keep out
    of reach of children. In case of accidental overdose, contact a
    doctor or a poison control center.
    Cautions
    Stop use if you are having rectal bleeding or failure to have a
    bowel movement after use. If adverse effects call 1-800-736-
    3437
    Unless directed by your doctor
    Do not take any laxative if you are having abdominal pain,
    nausea, or vomiting.
    Laxative products should not be used longer than a week.
    Ask a pharmacist or doctor if
    • You have noticed a sudden change in bowel habits that
    persist over two weeks after using this product.
    • You are pregnant or breast feeding before use.

  • INACTIVE INGREDIENT

    Water

  • STORAGE AND HANDLING

    Store at room temperature (59°F-86°F). Below 59°F cloudiness
    may occur. Application of heat may restore clarity and fluidity
    without affecting the quality of Sorbitol.
    DO NOT FREEZE.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental overdose, contact a
    doctor or a poison control center.   

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    SORBITOL 
    sorbitol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-700
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SORBITOL (UNII: 506T60A25R) (SORBITOL - UNII:506T60A25R) SORBITOL258.2 g  in 474 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54162-700-16474 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/31/2015
    2NDC:54162-700-3030 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product07/31/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33407/17/2012
    Labeler - Geritrex LLC (112796248)
    Registrant - Geritrex LLC (112796248)
    Establishment
    NameAddressID/FEIBusiness Operations
    Geritrex LLC112796248manufacture(54162-700)
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