Active Ingredient(In Each Suppository)
Glycerin, USP 1 grams
Glycerin Suppository
FDA Label NDC 13709-333
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Neilmed Pharmaceuticals Inc. for the product Glycerin (NDC 13709-333). 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 ingredient(in each suppository), purpose, uses, warnings, do not use, ask a doctor before use if you have, when using this product,, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Laxative
Uses
• relieves occasional constipation (irregularity)
• generally, produces bowel movement in ¼ to 1 hour
Warnings
For rectal use only
Do Not Use
laxative products for longer than 1 week unless directed by a doctor
Ask A Doctor Before Use If You Have
• stomach pain • nausea • vomiting • noticed a sudden change in bowel habits that lasts over 2 weeks
When Using This Product,
your child may have rectal discomfort or a burning sensation
Stop Use And Ask A Doctor If
your child has rectal bleeding or fails to have a bowel movement after use of a laxative. These could be signs of a serious condition.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Directions
| Children 2 to under 6 years | 1 suppository per day or as directed by a doctor |
| Children under 2 years | Ask a doctor |
Insert 1 suppository well into the rectum. To produce laxative action, suppository is designed to dissolve only partially and may not be noticeable
Other Information
• Store at room temperature. Do not exceed 30˚ C (86˚ F)
• Lot No. & Exp. Date: see wrapper or box
Inactive Ingredient
Purified water, sodium hydroxide, stearic acid
Questions Or Comments?
1(877) 477-8633
Important:
Please do not discard this printed box and any enclosed printed material. The inside final product may not have all the details you require for the ongoing use of the product.
* Please review the disclaimer below.
