DOCUSATE SODIUM capsule, liquid filled

DOCUSATE SODIUM by

Drug Labeling and Warnings

DOCUSATE SODIUM by is a Otc medication manufactured, distributed, or labeled by DIRECT RX. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 100 mg

OTC - PURPOSE SECTION

Stool softener

INDICATIONS & USAGE SECTION

• for prevention of dry, hard stools
• for relief of occasional constipation

This product generally produces a bowel movement within 12 to 72 hours.

WARNINGS SECTION

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

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

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

• adults and children over 12 years of age: take 1 to 3 softgels preferably at bedtime
• children 6-12 years of age: take 1 softgel at bedtime
• children under 6 years: ask a doctor

Other information

• each softgel contains: sodium 6 mg
• store between 15º-30ºC (59º-86ºF)

Questions or comments?

1-800-645-2158

Principal Display Panel

COMPARE TO ACTIVE INGREDIENT IN COLACE®*

NON-HABIT FORMING

Stool Softener Laxative

Docusate Sodium USP, 100 mg

SOFTGEL CAPSULES

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*Rugby Laboratories is not affiliated with the owner of the trademark Colace®.

Distributed by: Rugby Laboratories

31778 Enterprise Drive

Livonia, MI  48150

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

INACTIVE INGREDIENT SECTION

edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special.

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61919-459(NDC: 0536-3756)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	100 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	orange	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	P51
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61919-459-71	100 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 61919-459-30	30 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	01/01/2014

Labeler - DIRECT RX (079254320)

Establishment
Name	Address	ID/FEI	Business Operations
DIRECT RX		079254320	relabel(61919-459)