Label: GERICARE SORBITOL SOLUTION- sorbitol liquid

  • NDC Code(s): 57896-758-16
  • 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 29, 2020

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  • ACTIVE INGREDIENT

    Active Ingredient

    Sorbitol 70% USP

  • PURPOSE

    Purpose

    Laxative

  • INDICATIONS & USAGE

    Uses

    • releieves 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, ask your doctor
  • WARNINGS

    Warnings

    For rectal use only

    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

    • are taking mineral oil
    • have noticed a sudden change in bowel habits that lasts over 2 weeks

    Stop use and aska doctor if you have a rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions Do not exceed recommended dose

     AGE DOSE
     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 of age Ask a doctor

  • INACTIVE INGREDIENT

    Inactive ingredients water

  • QUESTIONS

    Questions or comments? 1-800-540-3765

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    GERICARE SORBITOL SOLUTION 
    sorbitol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-758
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SORBITOL (UNII: 506T60A25R) (SORBITOL - UNII:506T60A25R) SORBITOL70 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57896-758-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33401/01/2020
    Labeler - GERI-CARE PHARMACEUTICALS, CORP (611196254)
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