ADULT GLYCERIN LAXATIVE- glycerin suppository

Adult Glycerin Laxative by

Drug Labeling and Warnings

Adult 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 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

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®

INGREDIENTS AND APPEARANCE

ADULT GLYCERIN LAXATIVE  
glycerin suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49781-081
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	2 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: 49781-081-25	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(49781-081)