FDA.reportPublic FDA data

Stool Softener

Manufacturer
NuCare Pharmaceuticals,Inc. | NuCare Pharmaceuticals, Inc.
Effective date
2022-01-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:11:05

Label at a glance#

ProductStool Softener
Active ingredientDOCUSATE SODIUM
Label structure8 sections

Indications and uses

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

Dosage and administration

• adults and children 12 years and older: take 1-2 softgel daily until first bowel movement; 1 softgel daily thereafter, or as directed by doctor • children under 12: consult a doctor • do not exceed recommended dose

Storage and handling

• each softgel contains: sodium 5 mg. very low sodium • store at 15°C-25°C(59° F-77° F) • keep tightly closed • product from USA or Canada • Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

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

Ask a doctor before use if you

• have stomach pain, nausea or vomiting

• have a sudden change in bowel habits that persists over a period of 2 weeks

• are presently taking mineral oil

Stop use and ask a doctor if

• you need to use a laxative longer than 1 week

• you have rectal bleeding or fail to have a bowel movement. These

could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• adults and children 12 years and older: take 1-2 softgel daily until first bowel movement; 1 softgel daily thereafter, or as directed by doctor

• children under 12: consult a doctor

• do not exceed recommended dose

Other information

STORAGE AND HANDLING SECTION

• each softgel contains: sodium 5 mg. very low sodium

• store at 15°C-25°C(59° F-77° F)

• keep tightly closed

• product from USA or Canada

• Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C red #40, gelatin, glycerin, edible ink, PEG, propylene glycol, sorbitol special, water. Also contains D&C yellow #10
or FD&C yellow #6 (sunset yellow).

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-1656-02022-01-30C16284748780-1d6a99b39-f0b4-a426-e053-dadaa90af4c2GC 401(408)
68071-1656-02022-01-28C16284748780-1d6a99b39-f0b4-a426-e053-dadaa90af4c2GC 401(408)

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-408-01EA - Each57896-408a3a8f09f-f9bf-4aa2-ba09-5156be87c52f12019-03-12
57896-408-03EA - Each57896-408832d75ba-545f-4446-9985-7d6e39383f7f12019-04-11
57896-408-10EA - Each57896-408cbc35fd5-94e6-4160-821c-a22ccc3e4a2b12020-08-06
57896-408-20EA - Each57896-4085a868761-8bd5-4dff-bd9a-705a6a79935012019-04-11

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68071-165668071-1656-0
57896-408

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C RED NO. 40WZB9127XOAIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
MANNITOL3OWL53L36AIACT
DOCUSATE SODIUMF05Q2T2JA0ACTIB

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
1d4de5b6-bf1c-df95-e063-6294a90a70838023a475-4eef-863b-e053-2991aa0ab5162024-07-15WarningsExact identifier
spl set id: 8023a475-4eef-863b-e053-2991aa0ab516

Reported adverse events (FAERS/openFDA)#

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