EXTRA STRENGTH STOOL SOFTENER LAXATIVE by Rugby Laboratories, Inc. / P & L Development, LLC Drug Facts

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 Rugby Laboratories, Inc., P & L Development, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EXTRA STRENGTH STOOL SOFTENER LAXATIVE- docusate sodium capsule, liquid filled 
Rugby Laboratories, Inc.

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

These could be signs of a serious condition.

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: take1 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 between 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

Questions or comments?

1-800-645-2158

Principal Display Panel

Extra Strength Stool Softener Laxative
Docusate Sodium USP, 250 mg

SOFTGEL

CAPSULES

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

Distributed by: Rugby Laboratories

31778 Enterprise Drive

Livonia, MI  48150
www.rugbylaboratories.com

Package Label

Rugby Extra Strength Sool Softener Laxative Softgel

 

EXTRA STRENGTH STOOL SOFTENER LAXATIVE 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	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 GLYCOL, UNSPECIFIED (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: 0536-3757-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/29/2012	12/31/2019
2	NDC: 0536-3757-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	03/29/2012	12/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	03/29/2012	12/31/2019

Labeler - Rugby Laboratories, Inc. (079246066)

Registrant - P & L Development, LLC (800014821)

Revised: 12/2018

Document Id: 487cc305-09ae-4773-b2fe-3a3f471f4f82

34390-5

Set id: 18300b1c-71ff-4021-a5e6-c859ce4498c1

Version: 9

Effective Time: 20181220

 

Rugby Laboratories, Inc.