LAXATIVE GENTLE- docusate sodium capsule, liquid filled
Walgreen Company

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.

----------

Walgreens 44-655-Delisted

Active ingredient (in each liquid-filled capsule)

Docusate sodium 100 mg

Purpose

Stool softener laxative

Uses

relieves occasional constipation (irregularity)
generally produces bowel movement in 12 to 72 hours

Warnings

Do not use

if you are presently taking mineral oil, unless told to do so by a doctor.

Ask a doctor before use if you have

stomach pain
nausea
vomiting
noticed a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if

you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
you need to use a laxative for more than 1 week

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 (1-800-222-1222) right away.

Directions

take with a glass of water
take only by mouth. Doses may be taken as a single daily dose or in divided doses.

adults and children 12 years and over	take 1 to 3 capsules daily
children 2 to under 12 years of age	take 1 capsule daily
children under 2 years of age	ask a doctor

Other information

each capsule contains: sodium 6 mg
Very Low Sodium
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
protect from excessive humidity
see end flap for expiration date and lot number

Inactive ingredients

citric acid, edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, lecithin, mineral oil, polyethylene glycol, propylene glycol, purified water, sorbitol

Questions or comments?

1-800-426-9391

Principal display panel

Well at
Walgreens

NDC 0363-6550-56

Gentle
Laxative

Docusate Sodium USP 100 mg /
Stool Softener Laxative

• Gentle & easy relief of occasional constipation

25
LIQUID GELS

Actual Size

Compare to Dulcolax® Stool
Softener active ingredient‡‡

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

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD, DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com ©2015 Walgreen Co.
PRODUCT OF CHINA, PACKAGED AND
QUALITY ASSURED IN THE U.S.A.

ITEM 411797 W10058-1115-L

Walgreens Pharmacist Recommended.
Walgreens Pharmacist Survey Study, November 2014.

‡‡This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., owner of the registered trademark Dulcolax® Stool Softener.

50844 REV0115A65556

Walgreens 44-655

LAXATIVE GENTLE
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-6550
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	100 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
MINERAL OIL (UNII: T5L8T28FGP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	ORANGE	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	655
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-6550-56	1 in 1 CARTON	03/01/2015	08/13/2021
1		25 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	03/01/2015	08/13/2021

Labeler - Walgreen Company (008965063)

Name	Address	ID/FEI	Business Operations
Establishment
Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd		421293287	API MANUFACTURE(0363-6550)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	PACK(0363-6550)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	PACK(0363-6550)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	PACK(0363-6550)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(0363-6550)

Revised: 12/2019

Document Id: b2668293-ef8a-494d-8613-f02ca1cb4619

Set id: d27732c6-79cd-4622-b520-ef04fef3f450

Version: 7

Effective Time: 20191212

Walgreen Company