Stool Softener by Walgreens Drug Facts

Drug Details [pdf]

STOOL SOFTENER- docusate calcium capsule, liquid filled
Walgreens

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

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 at controlled room temperature 15º-30º (59º-86ºF)
do not use if imprinted safety seal under cap is broken or missing
≠≠This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Surfak® Stool Softener

Inactive ingredients

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

Questions or comments?

Call toll free: 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Stool Softener

Docusate Calcium 240 mg / Gentle Relief of Constipation

Once-a-day dosage
Sodium free

SOFTGELS

Compare to Surfak® Stool Softener active ingredient≠≠

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Product Label

Well at Walgreens Stool Softener Softgel

STOOL SOFTENER
docusate calcium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0170
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
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	Score	no score
Shape	CAPSULE	Size	21mm
Flavor		Imprint Code	P58
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 0363-0170-01	1 in 1 BOX	07/01/2012	12/31/2019
1		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part334	07/01/2012	12/31/2019

Labeler - Walgreens (008965063)

Revised: 12/2018

Document Id: 82ef4950-a84c-49d1-ade5-706ab1b925c0

Set id: 5e27737b-e645-4c7c-addb-b4c32c2fe21f

Version: 2

Effective Time: 20181228

Walgreens