PEDIATRIC GLYCERIN LAXATIVE- glycerin suppository

Pediatric Glycerin Laxative by

Drug Labeling and Warnings

Pediatric Glycerin Laxative by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, Inc., Acino Products LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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®. 

INGREDIENTS AND APPEARANCE

PEDIATRIC GLYCERIN LAXATIVE 
glycerin suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49781-080
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	1 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM STEARATE (UNII: QU7E2XA9TG)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49781-080-25	25 in 1 BOX

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	04/01/2014

Labeler - Cardinal Health, Inc. (097537435)

Registrant - Acino Products LLC (019385518)

Establishment
Name	Address	ID/FEI	Business Operations
Acino Products LLC		019385518	manufacture(49781-080)