FDA Label for Infant Glycerin Laxative
View Indications, Usage & Precautions
Infant Glycerin Laxative Product Label
The following document was submitted to the FDA by the labeler of this product Mckesson. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Glycerin, USP 80.7%
Purpose
Laxative
Use
For relief of occasional constipation
Warnings
For rectal use only. May cause rectal discomfort or a burning sensation.
Do Not Use
- more than one per day
- for a period of longer than one week unless directed by a doctor
- laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor
- if seal under product lid is damaged, missing or broken.
Ask A Doctor
- before use if you have noticed a sudden change in bowel habits that persists over a period of two weeks
- if you are pregnant or nursing a baby
Otc - Ask Doctor/Pharmacist
Otc - When Using
Stop Use And Ask A Doctor
If you have rectal bleeding or fail to have a bowel movement after using a laxative. This may indicate a serious condition.
Otc - Pregnancy Or Breast Feeding
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Children 2 - 6 years of age: carefully insert one suppository well into the rectum
- Do not use more than once per day
- Generally produces a bowel movement in 15 minutes to 1 hour
- Children under 2 years of age: ask a doctor.
Other
Other Information
- Store container tightly closed
- Store at room temperature: 15°- 30° C (59° - 86° F). Do not exceed 30° C (86° F).
Inactive Ingredients
Sodium stearate, purified water
Otc - Questions
Package Label
Sunmark®
COMPARE TO FLEET® ACTIVE INGREDIENT*
NDC 49348-158-05
Laxative
Suppositories
Glycerin
For fast, gentle relief of occasional constipation
PEDIATRIC
25 SUPPOSITORIES
Another Quality Product
Distributed by McKesson
One Post Street, San
Francisco, CA 94104
Money Back Guarantee
Please visit us at
www.sunmarkbrand.com
*This product is not manufactured or distributed by C.B.Fleet co., owner of
the registered trademark Fleet®.
USE ONLY IF PRINTED
INNER SEAL IS NOT BROKEN
OR MISSING
* Please review the disclaimer below.
