Gericare Sorbitol Solution Liquid
FDA Label NDC 57896-758

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Geri-care Pharmaceuticals, Corp for the product Gericare Sorbitol Solution (NDC 57896-758). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient

Sorbitol 70% USP

Otc - 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.

Otc - Pregnancy Or Breast Feeding

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

Otc - 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

Otc - Questions

Questions or comments? 1-800-540-3765

Package Label.Principal Display Panel

Image Description (Gerisorbitol)

Image Description (Gerisorbitol)

Image Description (Gerisorbitol)

Image Description (Gerisorbitol)

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