Sorbitol

Manufacturer: H&H Laboratories, Inc.
Effective date: 2013-06-10
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:35:40

Label at a glance#

ProductSorbitol

Active ingredientSORBITOL

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient in each tablespoon=15 ml Sorbitol 15gm

OTC - PURPOSE SECTION

Purpose-Laxative

INDICATIONS & USAGE SECTION

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 SECTION

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

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.

WARNINGS SECTION

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 SECTION

Inactive Ingredients: Purified Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MM1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52471-111-16	2019-11-27	C162847	48780-1	9855d018-e0b7-cd31-e053-dbdaa90ab51a	DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52471-111-16	Sorbitol	473 mL in 1 BOTTLE	SOLUTION	473		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52471-111	SORBITOL SOLUTION [H&H LABORATORIES, INC.]	1	Legacy NDC, 1 package rows	20130611_debf8549-7369-40e7-a594-bff433a7bbf0.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SORBITOL	ACTIVE INGREDIENT	506T60A25R	1
SORBITOL	ACTIVE MOIETY	506T60A25R	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

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

Sorbitol
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
52471-111	52471-111-16

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
Name	UNII	Kind
SORBITOL	506T60A25R	ACTIB
WATER	059QF0KO0R	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
f251e7d4-222e-4e0f-9317-2e75bdaa86f2			debf8549-7369-40e7-a594-bff433a7bbf0	2013-06-10	Warnings	Exact identifier spl id: f251e7d4-222e-4e0f-9317-2e75bdaa86f2 spl set id: debf8549-7369-40e7-a594-bff433a7bbf0

Reported adverse events (FAERS/openFDA)#

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