FDA.reportPublic FDA data

GeriCare Sorbitol Solution

Manufacturer
GERI-CARE PHARMACEUTICALS, CORP
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:30:30

Label at a glance#

ProductGeriCare Sorbitol Solution
Active ingredientSORBITOL
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Sorbitol 70% USP

OTC - PURPOSE SECTION

Purpose

Laxative

INDICATIONS & USAGE SECTION

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 SECTION

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 SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

Inactive ingredients water

OTC - QUESTIONS SECTION

Questions or comments? 1-800-540-3765

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GeriSorbitol758GeriSorbitol758

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1301959sorbitol 70 % Rectal SolutionPSN8
1301959sorbitol 700 MG/ML Rectal SolutionSCD8
1301959sorbitol 70 % Rectal SolutionSY8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57896-758-16GeriCare Sorbitol Solution473 mL in 1 BOTTLELIQUID4738

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-758-16ML - Milliliter57896-75811a9d340-5f7b-4953-8313-876e85b6b4ad12021-03-02

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57896-75857896-758-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SORBITOL506T60A25RACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GeriCare Sorbitol SolutionSORBITOLGERI-CARE PHARMACEUTICALS, CORPb4dd7a41-380e-d94b-e053-2a95a90ac34a2025-12-31WarningsExact identifier
ndc (package): 57896-758-16
ndc (product): 57896-758
ndc11 (package): 57896075816
spl id: 4742e156-da3c-2c87-e063-6394a90af4ce
spl set id: b4dd7a41-380e-d94b-e053-2a95a90ac34a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.