GLYCERIN suppository

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)

Available from:

H E B

INN (International Name):

GLYCERIN

Composition:

GLYCERIN 1 g

Administration route:

RECTAL

Prescription type:

OTC DRUG

Therapeutic indications:

Laxative - for relief of occassional constipation - this product generally produces bowel movement in 1/4 to 1 hour

Authorization status:

OTC monograph not final

Summary of Product characteristics

GLYCERIN- GLYCERIN SUPPOSITORY
H E B
----------
H E B PEDIATRIC GLYCERIN SUPPOSITORIES
ACTIVE INGREDIENT (IN EACH SUPPOSITORY)
Glycerin 1g
PURPOSE
Laxative
USES
for relief of occassional constipation
this product generally produces bowel movement in 1/4 to 1 hour
WARNINGS
FOR RECTAL USE ONLY
May cause rectal discomfort or a burning sensation.
ASK A DOCTOR BEFORE USING ANY LAXATIVE IF CHILD HAS
abdominal pain, nausea or vomiting
a sudden change in bowel habits lasting more than 2 weeks
already used a laxative formore than 1 week
STOP USE AND CONSULT A DOCTOR IF CHILD HAS
rectal bleeding
no bowel movement within 1 hour using this product
These symptoms may indicate a serious condition.
KEEP OUT OF REACH OF CHILDREN
IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER
RIGHT AWAY.
DIRECTIONS - SINGLE DAILY DOSE
children 2 to under 6 years - 1 suppository, or as directed by a
doctor
chidren under 2 - ask a doctor
Insert suppository well up into rectum. Suppository need not melt
completely to
produce laxative action.
OTHER INFORMATION
Store container tightly closed.
Keep away from excessive heat.
INACTIVE INGREDIENTS
purified water, sodium hydroxide, stearic acid
QUESTIONS OR COMMENTS?
1-800-492-5988
LABEL
The product package shown below represents a sample of that currently
in use.
Additional packaging may also be available.
Pediatric Glycerin Suppositories, 25 count
Distributed by H-E-B, San Antonio, TX 78204 1002
HEBPed25.jpg
GLYCERIN
glycerin suppository
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:37808-399
ROUTE OF ADMINISTRATION
RECTAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)
GLYCERIN
1 g
H E B
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
SODIUM HYDROXIDE (UNII: 55X04QC32I)
STEARIC ACID (UNII: 4ELV7Z65AP)
WATER (UNII: 059QF0KO0R)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:37808-399-
25
25 in 1 JAR; Type 0: Not a Combination
Product
09/23/2