Active Ingredient
(in each suppository)
Glycerin 2 g
Fleet Suppository
FDA Label NDC 0132-0075
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by C.b. Fleet Company, Inc. for the product Fleet (NDC 0132-0075). 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, purpose, uses, warnings, do not use, ask a doctor before, when using this product, stop using this product and consult a doctor if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Hyperosmotic laxative
Uses
- for relief of occasional constipation
- this product usually produces bowel movement in ¼ to 1 hour
Warnings
For rectal use only.
Do Not Use
laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor.
Ask A Doctor Before
using any laxative if you
- have a sudden change in bowel habits lasting more than 2 weeks
- already used a laxative for more than 1 week
When Using This Product
rectal discomfort or burning sensation may occur.
Stop Using This Product And Consult A Doctor If You Have
- rectal bleeding
- no bowel movement within 1 hour of using this product
These symptoms may indicate a serious condition.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
Single Daily Dosage (per 24 hours)
| adults and children 6 years and over | 1 suppository or as directed by a doctor |
| children 2 to under 6 years | use Fleet® Pedia-Lax™ Suppositories |
| children under 2 years | consult a doctor |
Insert suppository well up into rectum, to produce laxative action. Suppository is designed to dissolve only partially, which may not be noticeable.
Other Information
• Store container tightly closed
• Keep away from excessive heat
• Mouth of jar sealed for safety. If foil imprinted with green Fleet® emblem is missing or torn, do not use.
Inactive Ingredients
aloe vera leaf, edetate disodium, purified water, sodium hydroxide, stearic acid
Questions?
1-866-255-6960 or www.fleetlabs.com
Principal Display Panel
Fleet®
Glycerin
Laxative suppositories
12 adult suppositories
Fleet® Glycerin Laxative Suppositories12 Adult Suppositories (Fleet Glycerin Suppository 01)
Fleet®
Glycerin
Laxative suppositories
24 adult suppositories
Fleet® Glycerin Laxative Suppositories24 Adult Suppositories (Fleet Glycerin Suppository 02)
Fleet®
Glycerin
Laxative suppositories
50 adult suppositories
Fleet® Glycerin Laxative Suppositories50 Adult Suppositories (Fleet Glycerin Suppository 03)
Fleet®
Glycerin
Laxative suppositories
100 adult suppositories
Fleet® Glycerin Laxative Suppositories100 Adult Suppositories (Fleet Glycerin Suppository 04)
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