Stool Softener by Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) / P & L Development, LLC Drug Facts

Stool Softener by

Drug Labeling and Warnings

Stool Softener by is a Otc medication manufactured, distributed, or labeled by Dolgencorp, Inc. (DOLLAR GENERAL & REXALL), P & L Development, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STOOL SOFTENER MAXIMUM STRENGTH- docusate sodium capsule, liquid filled 
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient (in each softgel)

Docusate Sodium 250 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 more 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 of age and over: take 1 softgel daily or as directed by a doctor
• children under 12 years of age: take as directed by a doctor

Other information

• each softgel contains: sodium 15 mg
• store at controlled room temperature 15º-30ºC (59º-86ºF)

Inactive ingredients

edible white ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special

Principal Display Panel

Maximum Strength

Stool Softener

Docusate Sodium, 250 mg

• Relieves constipation

Softgels

Visit us at: Rexall.com or call 1-866-4-REXALL

PACKAGED FOR DOLGENCORP, LLC

100 MISSION RIDGE

GOODLETTSVILLE, TN  37072  USA

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Package Label

Rexall Maximum Strength Stool Softener Softgel

 

STOOL SOFTENER  MAXIMUM STRENGTH
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-150
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 GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	ORANGE	Score	no score
Shape	CAPSULE	Size	20mm
Flavor		Imprint Code	P20
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-150-10	1 in 1 BOX	04/30/2013	01/01/2020
1		100 in 1 BOTTLE, PLASTIC; 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	04/30/2013	01/01/2020

Labeler - Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) (068331990)

Registrant - P & L Development, LLC (800014821)

Revised: 12/2018

Document Id: 22e42d5b-6f7a-448a-b550-c5e8f00e0df6

34390-5

Set id: fb650726-b307-46df-9d68-efe5dc027a34

Version: 2

Effective Time: 20181203

 

Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)