EXTRA STRENGTH STOOL SOFTENER LAXATIVE- docusate sodium capsule, liquid filled

EXTRA STRENGTH STOOL SOFTENER LAXATIVE by

Drug Labeling and Warnings

EXTRA STRENGTH STOOL SOFTENER LAXATIVE by is a Otc medication manufactured, distributed, or labeled by Dispensing Solutions, Inc., PSS World Medical, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each softgel)

Docusate Sodium 250mg

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
  
• children under 12 years: ask a doctor
  

Other information

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

Each capsule contains sodium 15mg

Inactive Ingredients

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

Questions or comments?

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

Product Labeling

Rugby Extra Strength Stool Softener Laxative
Docusate Sodium USP, 250mg

Mfd for: Rugby Laboratories, Inc
Duluth Georgia 30097
www.rugbylaboratories.com

Package Label

NDC: 66336-0010-XX

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH STOOL SOFTENER LAXATIVE 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66336-010(NDC: 0536-3757)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	250 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	20mm
Flavor		Imprint Code	P20
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66336-010-20	20 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 - Dispensing Solutions, Inc. (066070785)

Registrant - PSS World Medical, Inc. (101822682)

Establishment
Name	Address	ID/FEI	Business Operations
Dispensing Solutions, Inc.		066070785	relabel(66336-010) , repack(66336-010)