FDA Label for Glycerin Laxative

View Indications, Usage & Precautions

Glycerin Laxative Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health. 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 (In Each Suppository)



Glycerin, USP 2.1 grams


Purpose



Laxative


Uses



  • relieves occasional constipation (irregularity)

  • generally produces bowel movement in 1 ⁄ 4 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 This 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 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.


Directions



adults and children
6 years and over

1 suppository per day or as
directed by a doctor

children 2 to under 6 years

use pediatric glycerin suppositories

children under 2 years

ask a doctor

  • insert 1 suppository well up into rectum and retain for 15 minutes

  • it need not melt to produce laxative action


Other Information



  • keep tightly closed

  • avoid excessive heat


Inactive Ingredients



purified water, sodium hydroxide, stearic acid


Principal Display Panel



NDC 37205-320-63

LEADER®

Glycerin Suppositories

LAXATIVE

Compare to Fleet® active ingredient*

SATISFACTION GUARANTEED

Tamper Evident. Do not use if printed inner seal is broken or missing.

25 Adult Size

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
CIN 1390723
www.myleader.com
1-800-200-6313

All Leader® Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.

*Fleet® is a registered trademark of C.B. Fleet Co., Inc.

19-10126LR3C


* Please review the disclaimer below.