Your browser does not support JavaScript! ADULT GLYCERIN LAXATIVE (GLYCERIN) SUPPOSITORY [CARDINAL HEALTH, INC.]
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ADULT 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 2 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 you have

  • abdominal pain, nausea or vomiting.
  • a sudden change in bowel habits lasting for more than 2 weeks.
  • already used a laxative for more than 1 week.

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.

If pregnant or breastfeeding,

ask a doctor before use.

Directions

Single Daily dosage: 1 suppository or as directed by a doctor

  • Adults and children 6 years and over:
  • detach 1 suppository from the strip; remove the 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
  • insert one suppository well up into the rectum
  • children 2 to 6 years use Leader Pediatric Glycerin Suppositories
  • children under 2 years of age ask a doctor
Acion Leader image1

Inactive ingredients

sodium stearate, purified water

Other information

  • This product usually produces a bowel movement in 1/4 to 1 hour
  • Store container tightly closed
  • Keep from excessive heat

Adult Glycerin Suppositories Label

NDC 49718-081-25

Leader®

Compare to Fleet® active ingredient*

Glycerin Suppositories
Laxative

SATISFACTION GUARANTEED

25 Adult 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, OH 43017  CIN # 4866216
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®

Ancino GlySupp 081 Label


ADULT GLYCERIN LAXATIVE  
glycerin suppository
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49781-081
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (GLYCERIN) GLYCERIN2 g
Inactive Ingredients
Ingredient NameStrength
SODIUM STEARATE 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49781-081-2525 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(49781-081)

Revised: 3/2014
 
Cardinal Health, Inc.

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