Stool Softener DC Laxative by Rugby Laboratories, Inc. / P & L Development, LLC Drug Facts

Stool Softener DC Laxative by

Drug Labeling and Warnings

Stool Softener DC 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]

STOOL SOFTENER DC LAXATIVE- docusate calcium 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 Calcium 240 mg

Purpose

Stool softener

Uses

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 longer 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 s 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.

Directions

• adults and children over 12 years of age: take 1 softgel daily for several days, or until bowel movements are normal, or as directed by a doctor
• children under 12 years of age: take as directed by a doctor

Other information

• store between 15º-30ºC (59º-86ºF)

Inactive ingredients

corn oil, D&C red #33, edible white ink, FD&C red #40, gelatin, glycerin, purified water and sorbitol special.

Questions or comments?

1-800-645-2158

Principal Display Panel

Compare to active ingredient in SURFAK®*

Safe, Effective, Non-Habit Forming

Stool Softener Laxative DC

Docusate Calcium USP, 240 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 Surfak®.

Distributed by: Rugby Laboratories

31778 Enterprise Drive

Livonia, MI  48150

www.rugbylaboratories.com

Product Labeling

Rugby Stool Softener Laxative DC Softgel

 

STOOL SOFTENER DC LAXATIVE 
docusate calcium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-3755
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE CALCIUM (UNII: 6K7YS503HC) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE CALCIUM	240 mg

Inactive Ingredients
Ingredient Name	Strength
CORN OIL (UNII: 8470G57WFM)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	RED (RED)	Score	no score
Shape	OVAL (OVAL)	Size	8mm
Flavor		Imprint Code	P58
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-3755-01	1 in 1 BOX	12/01/2011	12/31/2019
1		100 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 0536-3755-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2011	12/31/2019
3	NDC: 0536-3755-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2011	12/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	12/01/2011	12/31/2019

Labeler - Rugby Laboratories, Inc. (079246066)

Registrant - P & L Development, LLC (800014821)

Revised: 12/2018

Document Id: 79ce8637-c430-4239-b523-0f4c8b92e4cb

34390-5

Set id: cd26573c-18fb-4f37-84bf-41a664f2764c

Version: 7

Effective Time: 20181220

 

Rugby Laboratories, Inc.