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  5. Label Information: Pediatric Glycerin Laxative

FDA Label for Pediatric Glycerin Laxative

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS ACTIVE INGREDIENT
    2. PURPOSE
    3. KEEP OUT OF REACH OF CHILDREN.
    4. USE
    5. WARNINGS
    6. ASK A DOCTOR BEFORE USE IF YOUR CHILD HAS
    7. STOP USE AND ASK A DOCTOR IF YOUR CHILD HAS
    8. IF PREGNANT OR BREASTFEEDING,
    9. DIRECTIONS
    10. INACTIVE INGREDIENTS
    11. OTHER INFORMATION
    12. PEDIATRIC GLYCERIN SUPPOSITORY LABEL

Pediatric 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.

Drug Facts Active Ingredient



(per suppository)

Glycerin, USP 1 g


Purpose



Laxative


Keep Out Of Reach Of Children.



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1212).


Use



For relief of occasional constipation


Warnings



For rectal use only. May cause rectal discomfort or burning sensation.


Ask A Doctor Before Use If Your Child Has



  • abdominal pain,nausea,or vomiting.
  • a sudden change in bowel habits lasting more than 2 weeks.
  • if you have already used a laxative for a week

Stop Use And Ask A Doctor If Your Child Has



rectal bleeding or fails to have a bowel movement within one  hour of using this product.
This may indicate a serious condition.


If Pregnant Or Breastfeeding,



ask a doctor before use.


Directions



  • Children 2 to under 6 years:
  • detach 1 suppository from the strip; remove wrapper before inserting into the rectum as follows:
  • hold suppository with pointed end up
  • carefully separate tabs with fingernail
  • slowly pull apart by pulling tabs down on both sides
  • remove suppository from wrapper
  • Carefully insert one suppository well into the rectum and retain for 15 minutes
  • It need not melt completely to produce laxative action
  • Generally produces bowel movement in 15 minutes to 1 hour
  • Do not exceed one suppository daily unless directed by a doctor
  • Children under 2 years: consult a doctor
    • Acino Leader image1 - Acino Leader image1

    Acino Leader image1 - Acino Leader image1


Inactive Ingredients



sodium stearate, purified water


Other Information



  • Store container tightly closed
  • Keep from excessive heat

Pediatric Glycerin Suppository Label



NDC 49781-080-25

LEADER®

Compare to Fleet® active ingredient*

Pediatric Glycerin Suppositories
Laxative

SATISFACTION GUARANTEED

25 Pediatric Size

TAMPER-EVIDENT: FOR YOUR SAFETY , SUPPOSITORIES ARE PACKED IN TAMPER-EVIDENT SEALED WRAPPER. DO NOT USE IF WRAPPER IS TORN OR OPEN

E-Z Open Wrapper

Distributed by Cardinal Health, Inc.
Dublin, Ohio 43017
CIN 4873303
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.

This product is not manufactured or distributed by C.B. Fleet Co. Inc., owner of the registered trademark Fleet®. 

Acino GlySupp 080 - Acino GlySupp 080

Acino GlySupp 080 - Acino GlySupp 080


* Please review the disclaimer below.