Label: SORBITOL solution

  • Category: HUMAN OTC DRUG LABEL

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 June 10, 2013

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  • ACTIVE INGREDIENT

    Active Ingredient in each tablespoon=15 ml   Sorbitol 15gm

  • PURPOSE

    Purpose-Laxative

  • INDICATIONS & USAGE

    Uses-Relieves occasional constipation and irregularity.  Generally produces bowel movement in 1/4 to 1 hour when used rectally.  As a pharmaceutical aid (sweetener). For other uses, ask your doctor.

  • DOSAGE & ADMINISTRATION

    Directions: For adults and children 12 years or older: Dose-2 tablespoons.  maximum single dose-4 tablespoons.  Not to exceed 6 tablespoons daily

  • 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.

  • WARNINGS

    Warnings: Do not use:  When abdominal pain, nausea, or vomiting are present for more than a week unless directed by a doctor.

    Ask a doctor before use if you-are taking mineral oil, have noticed a sudden change in bowel habi9ts that lasts over 2 weeks.

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






      

  • INACTIVE INGREDIENT

    Inactive Ingredients: Purified Water

  • PRINCIPAL DISPLAY PANEL

    MM1

    sorbitol label


  • INGREDIENTS AND APPEARANCE
    SORBITOL 
    sorbitol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52471-111
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SORBITOL (UNII: 506T60A25R) (SORBITOL - UNII:506T60A25R) SORBITOL1 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52471-111-16473 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33406/10/2013
    Labeler - H&H Laboratories, Inc. (151357175)
    Registrant - H&H Laboratories, Inc. (151357175)
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