Label: SORBITOL solution

  • NDC Code(s): 57896-435-16
  • Packager: Geri-Care Pharmaceuticals, Corp
  • 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 December 19, 2018

If you are a consumer or patient please visit this version.

  • Active ingredient (In each 15 mL tablespoonful)

    Sorbitol 13.5 g

  • Purpose

    Laxative

  • Uses

    • relieves occasional constipation and irregularity
    • generally produces bowel movement in 1/4 to 1 hour when used rectally
    • as a pharmaceutical aide (sweetner)
    • for other uses, as your doctor

  • Warnings

    Do not use

    • when abdominal pain, nausea, or vomiting are present
    • for more than one week unless directed by a doctor
      Ask a doctor before use if you
    • are taking mineral oil
    • have noticed a sudden change in bowel habits that lasts over 2 weeks
      Stop use and ask a doctor if

    you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. In case of overdose, get medical help or contact a

    Poison Control Center right away.

  • Directions

    • do not exceed recommended dose
    AgeDose
    adults and
    children
    12 years
    and over
    For rectal use only. Enema dosage
    is 120 mL of a 25 to 30% w/v solution
    (1 part of this product with 2.3 parts water) in a single daily dose as needed, or as
    directed by your doctor.
    children under
    12 years
    Ask a doctor

  • Other information

    • store at room temperature 15-30C (59-86F)
    • below 59F cloudiness and thickening may occur; warming will restore clarity and fluidity without affecting product quality
    • do not freeze
    • store in original container
  • Inactive ingredient

    water

  • Questions or comments?

    1-800-540-3765

  • package Label

    1

  • INGREDIENTS AND APPEARANCE
    SORBITOL 
    sorbitol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-435
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SORBITOL (UNII: 506T60A25R) (SORBITOL - UNII:506T60A25R) SORBITOL13.5 g  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57896-435-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33401/01/2000
    Labeler - Geri-Care Pharmaceuticals, Corp (611196254)
    Registrant - GCP Laboratories (965480861)
    Establishment
    NameAddressID/FEIBusiness Operations
    GCP LABORATORIES965480861manufacture(57896-435) , pack(57896-435)