Sorbitol
FDA Label NDC 54162-700

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Geritrex Llc for the product Sorbitol (NDC 54162-700). 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 active ingredients, uses, directions, dosage & administration, warnings, inactive ingredient, storage and handling, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

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

Uses

For occasional relief of constipation.

Directions

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

Dosage & Administration

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

Warnings

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

Water

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.

Otc - Keep Out Of Reach Of Children

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

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