Drug Facts: Active Ingredient
Active ingredient (in each suppository)
Glycerin, USP 2 grams
Glycerin Laxative Suppository
FDA Label NDC 13709-329
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 Laxative (NDC 13709-329). 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 drug facts: active ingredient, drug facts, uses, warnings, do not use, ask a doctor before use if you have, when using the 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
Drug Facts
Active ingredient (in each suppository) ...............Purpose
Glycerin, USP 2 grams ...................................... Laxative
Uses
• Relieves occasional constipation (irregularity)
• Generally produces bowel movement in 15 minutes 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
• Abdominal pain • Nausea • Vomiting • Noticed a sudden change in bowel habits that lasts over 2 weeks
When Using The Product
you may have rectal discomfort or a burning sensation.
Stop Use And Ask A Doctor If
- You have rectal bleeding
- You fail to have a bowel movement after use of a laxative. These could be a signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Directions
| Adults and children 6 years of age and over | 1 suppository per day or as directed by a doctor. |
| Children 2 to under 6 years | Use Neilmed Child Suppositories |
| 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 Ingredients
Purified water, sodium hydroxide, stearic acid
Questions?
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.
Package Label.Principal Display Panel
Glycerin Laxative Suppositories (Glycerin)
* Please review the disclaimer below.
