NON-HABIT FORMING STOOL SOFTENER- docusate sodium capsule, liquid filled

Non-Habit Forming Stool Softener by

Drug Labeling and Warnings

Non-Habit Forming Stool Softener by is a Otc medication manufactured, distributed, or labeled by Rebel Distributors Corp, PSS World Medical, Inc., STAT RX USA LLC, Dispensing Solutions, Inc., SCRIPT PAK, Keltman Pharmaceuticals, Inc., Rebel Distirbutors Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each softgel capsule)

Docusate Sodium 100mg

Purpose

Stool softener

Uses

• Relieves occasional constipation.
• Generally produces bowel movement within 12 to72 hours.

Warnings - Do not use

• for longer than one week
• if you are taking mineral oil
• when abdominal pain, nausea, or vomiting are present

Ask a doctor before use if

you have a sudden change in bowel habits that lasts over two weeks

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Stop use and ask a doctor if

• you experience rectal bleeding
• you fail to have a bowel movement after using this product

These may indicate a serious condition.

If pregnant or breastfeeding

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 over 12 years and over:1 capsule once daily or in divided doses
• children 6 to under 12 years: 1 capsule once daily
• children under 6 years: ask a doctor

Other information

• store at controlled room temperature 15 - 30 degrees C (59-86 degrees F)

Each capsule contains sodium 6mg

Inactive Ingredients

edible white ink, FDandC Red No. 40, FDandC Yellow No. 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special.

Questions or comments?

Call 1-800-645-2158, 9am - 5am ET Monday - Friday

Principal Display Panel

INGREDIENTS AND APPEARANCE

NON-HABIT FORMING STOOL SOFTENER 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42254-125(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 (orange)	Score	no score
Shape	OVAL (OVAL)	Size	13mm
Flavor		Imprint Code	P51
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42254-125-30	30 in 1 BOTTLE
2	NDC: 42254-125-60	60 in 1 BOTTLE
3	NDC: 42254-125-00	100 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	03/29/2012

Labeler - Rebel Distributors Corp (118802834)

Registrant - PSS World Medical, Inc. (101822862)

Establishment
Name	Address	ID/FEI	Business Operations
PSS World Medical, Inc.		791528623	REPACK(42254-125)

Establishment
Name	Address	ID/FEI	Business Operations
STAT RX USA LLC		786036330	REPACK(42254-125)

Establishment
Name	Address	ID/FEI	Business Operations
Dispensing Solutions, Inc.		066070785	RELABEL(42254-125) , REPACK(42254-125)

Establishment
Name	Address	ID/FEI	Business Operations
SCRIPT PAK		964420108	RELABEL(42254-125) , REPACK(42254-125)

Establishment
Name	Address	ID/FEI	Business Operations
Keltman Pharmaceuticals, Inc.		362861077	REPACK(42254-125)

Establishment
Name	Address	ID/FEI	Business Operations
Rebel Distirbutors Corp.		118802834	RELABEL(42254-125) , REPACK(42254-125)