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 Physicians Total Care, Inc.. 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
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.
Keep Out Of Reach Of Children
- If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Ask Doctor/Pharmacist
Enter section text here
Otc - When Using
Enter section text here
Otc - Pregnancy Or Breast Feeding
Enter section text here
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 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
Questions
Adverse Drug Event Call: (800) 616-2471
Principal Display Panel
NDC 54868-6186-0
Infant
GLYCERIN
SUPPOSITORIES
Rectal evacuant
For relief of
temporary
constipation
12 Infant Suppositories
Compare to Fleet® Glycerin Suppositories*
*This product is not
manufactured or distributed by C.B.Fleet co., owner of
the registered
trademark Fleet®.
Distributed by:
Major Pharmaceuticals
31778 Enterprise
Drive
Livonia, MI 48150 USA
Reorder No. 233874
M-54 Rev 6/08
DO NOT USE IF PRINTED
INNER SEAL IS BROKEN
OR MISSING
Relabeling of "Additional Barcode Label" by:
Physicians Total Care, Inc.
Tulsa, OK 74146
* Please review the disclaimer below.