Otc - Active Ingredient
Active Ingredient in each tablespoon=15 ml Sorbitol 15gm
Sorbitol
FDA Label NDC 52471-111
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by H&h Laboratories, Inc. for the product Sorbitol (NDC 52471-111). 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, dosage & administration, otc - keep out of reach of children, warnings, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose-Laxative
Indications & Usage
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
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
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Warnings
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
Inactive Ingredients: Purified Water
Package Label.Principal Display Panel
MM1
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