FDA.reportPublic FDA data

Stool Softener

Manufacturer
L.N.K. International, Inc. | Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd | LNK International, Inc.
Effective date
2020-10-12
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 23:12:00

Label at a glance#

ProductStool Softener
Active ingredientDOCUSATE SODIUM
Label structure9 sections

Indications and uses

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

Dosage and administration

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 

Storage and handling

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 

Label contents#

Full prescribing information#

Active ingredient (in each liquid-filled capsule)

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium 100 mg

Purpose

OTC - PURPOSE SECTION

Stool softener laxative

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you have rectal bleeding or fail to have a bowl 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 overtake 1 to 3 capsules daily
 children 2 to under 12 years of agetake 1 capsule daily 
children under 2 years of age ask a doctor 

Other information

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Quality 
+ Plus

NDC 50844-655-56

*Compare to active ingredient in
Dulcolax® Stool Softener 

STOOL SOFTENER 

Docusate Sodium 100 mg
STOOL SOFTENER LAXATIVE

Comfortable, Stimulant-Free
Constipation Relief

25 Liquid Gels

ACTUAL SIZE

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

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

50844    ORG011565556

Product of China
Packaged and Quality Assured in the USA

Distributed by:
LNK INTERNATIONAL, INC.
60 Arkay Drive
Hauppauge, NY 11788
USA

Quality Plus 44-655
Quality Plus 44-655

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50844-65550844-655-56

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
DOCUSATE SODIUMF05Q2T2JA0ACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
MINERAL OILT5L8T28FGPIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITOL506T60A25RIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0e658a1c-e51a-42e1-b0fd-707273dda4284232defb-7b05-4cae-b59d-f43bbf2a0a482021-05-03WarningsExact identifier
spl set id: 4232defb-7b05-4cae-b59d-f43bbf2a0a48

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.