Active ingredient (in each capsule)

Docusate Sodium 100 mg

Purpose

Stool softener

Uses

for the prevention of dry, hard stools
for relief of occasional constipation
This product generally produces a bowel movement within 12 to 72 hours.

Warnings

Do not use

if you are currently taking mineral oil, unless directed by a doctor
when abdominal pain, nausea, or vomiting are present
for longer than 1 week unless directed by a doctor

Ask a doctor before use if you notice a sudden change in bowel habits that persists over a period of 2 weeks.

Stop use and ask a doctor if

you have rectal bleeding
you fail to have a bowel movement after use

If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years and over: take 1 to 2 capsules, preferably at bedtime
Children 6-12 years of age: take 1 capsule at bedtime

Other information

each capsule contains: sodium 6 mg
store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]
keep away from heat - do not refrigerate
do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

Gelatin, Polyethylene Glycol 400, Sorbitol Special™ (sorbitol, sorbitol anhydrides, purified water and mannitol), Glycerin, USP, Purified Water, USP, Propylene Glycol, USP, FD&C Red #40, FD&C Yellow #6, Edible white printing ink

Questions ?

1 800 328 5113 Serious side effects associated with use of this product may be reported to this number.

PRINCIPAL DISPLAY PANEL - 100 mg Bottle Label

NDC 0574-0101-01
DOCUSATE
SODIUM

100 mg

Stool Softener

NET CONTENTS
100 CAPSULES

Paddock
Laboratories, Inc.

PRINCIPAL DISPLAY PANEL - 100 mg Bottle Label

DOCUSATE SODIUM
docusate sodium capsule

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	0574-0101
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (DOCUSATE)	DOCUSATE SODIUM	100 mg

Inactive Ingredients
Ingredient Name	Strength
GELATIN
POLYETHYLENE GLYCOL 400
SORBITOL
WATER
MANNITOL
GLYCERIN
PROPYLENE GLYCOL
FD&C RED NO. 40
FD&C YELLOW NO. 6

Product Characteristics
Color	ORANGE, RED	Score	no score
Shape	CAPSULE	Size	13mm
Flavor		Imprint Code	P51
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0574-0101-01	100 CAPSULE In 1 BOTTLE	None
2	0574-0101-10	1000 CAPSULE In 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358G	05/27/1987	10/26/2011

Labeler - Paddock Laboratories, Inc. (086116803)

Establishment
Name	Address	ID/FEI	Operations
Paddock Laboratories, Inc.		086116803	MANUFACTURE

Revised: 05/2010Paddock Laboratories, Inc.