Your browser does not support JavaScript! PEDIATRIC GLYCERIN LAXATIVE (GLYCERIN) SUPPOSITORY [CARDINAL HEALTH, INC.]
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PEDIATRIC GLYCERIN LAXATIVE (glycerin) suppository
[Cardinal Health, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

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

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

PEDIATRIC GLYCERIN LAXATIVE 
glycerin suppository
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49781-080
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (GLYCERIN) GLYCERIN1 g
Inactive Ingredients
Ingredient NameStrength
SODIUM STEARATE 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49781-080-2525 in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33404/01/2014
Labeler - Cardinal Health, Inc. (097537435)
Registrant - Acino Products LLC (019385518)
Establishment
NameAddressID/FEIBusiness Operations
Acino Products LLC019385518manufacture(49781-080)

Revised: 3/2014
 
Cardinal Health, Inc.

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