FDA.reportPublic FDA data

Sorbitol Solution

Manufacturer
Geritrex LLC
Effective date
2018-01-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:54:11

Label at a glance#

ProductSorbitol
Active ingredientSORBITOL
Label structure9 sections

Indications and uses

For occasional relief of constipation.

Dosage and administration

For adults or children 12 years or over. Use 2-4 TBSP (30-60ml) daily or as directed by a Physician.

Storage and handling

Store at room temperature (59°F-86°F). Below 59°F cloudiness may occur. Application of heat may restore clarity and fluidity without affecting the quality of Sorbitol. DO NOT FREEZE.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients . . . . . . . .Purpose
Sorbitol 70% . . . . . . . . . . . . .Laxative

Uses

OTC - PURPOSE SECTION

For occasional relief of constipation.

Directions

INDICATIONS & USAGE SECTION

For adults or children 12 years or over. Use 2-4 TBSP (30-60ml)
daily or as directed by a Physician.

DOSAGE & ADMINISTRATION SECTION

Use 2-4 TBSP (30-60ml)
daily or as directed by a Physician.

Warnings

WARNINGS SECTION

This product does not contain a child resistant cap. Keep out
of reach of children. In case of accidental overdose, contact a
doctor or a poison control center.
Cautions
Stop use if you are having rectal bleeding or failure to have a
bowel movement after use. If adverse effects call 1-800-736-
3437
Unless directed by your doctor
Do not take any laxative if you are having abdominal pain,
nausea, or vomiting.
Laxative products should not be used longer than a week.
Ask a pharmacist or doctor if
• You have noticed a sudden change in bowel habits that
persist over two weeks after using this product.
• You are pregnant or breast feeding before use.

INACTIVE INGREDIENT SECTION

Water

STORAGE AND HANDLING SECTION

Store at room temperature (59°F-86°F). Below 59°F cloudiness
may occur. Application of heat may restore clarity and fluidity
without affecting the quality of Sorbitol.
DO NOT FREEZE.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental overdose, contact a
doctor or a poison control center.   

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313092sorbitol 70 % Oral SolutionPSN2
313092sorbitol 700 MG/ML Oral SolutionSCD2
313092sorbitol 70 % Oral SolutionSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54162-700-162020-01-31C16284748780-19d75b9d0-c0ee-f424-e053-dadaa90a57ceSorbitol Solution
54162-700-302020-01-31C16284748780-19d75b9d0-c0ee-f424-e053-dadaa90a57ceSorbitol Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54162-700-16Sorbitol474 mL in 1 BOTTLE, PLASTICSOLUTION4742
54162-700-30Sorbitol30 mL in 1 CUP, UNIT-DOSESOLUTION302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54162-700SORBITOL SOLUTION [GERITREX LLC]2Legacy NDC, 2 package rows20180119_ae9a1c12-8662-4f5d-8435-e51dc2b45780.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54162-700-16ML - Milliliter54162-700583e70eb-30e1-4669-8810-354ff631eafb12016-05-16
54162-700-30ML - Milliliter54162-7006123eea7-7398-49be-8d91-42448ac71a4712016-05-16

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54162-70054162-700-16, 54162-700-30

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
SORBITOL506T60A25RACTIB
WATER059QF0KO0RIACT

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
f0aa7245-b91f-499c-b009-77b00e41c9c8ae9a1c12-8662-4f5d-8435-e51dc2b457802018-01-17WarningsExact identifier
spl id: f0aa7245-b91f-499c-b009-77b00e41c9c8
spl set id: ae9a1c12-8662-4f5d-8435-e51dc2b45780

Reported adverse events (FAERS/openFDA)#

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