FDA.reportPublic FDA data

Stool Softener

Manufacturer
Bryant Ranch Prepack
Effective date
2024-07-05
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:14:46

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

• do not exceed recommended dose • adults and children 12 years and older: take 1-3 softgels daily until first bowel movement; 1 softgel daily thereafter, or as directed by a doctor • children under 12: consult a doctor

Storage and handling

• each softgel contains: sodium 7 mg. Very low sodium • store at 59°-77°F (15°-25°C) • keep tightly closed • 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

• do not exceed recommended dose
• adults and children 12 years and older: take 1-3
softgels daily until first bowel movement; 1 softgel
daily thereafter, or as directed by a doctor
• children under 12: consult a doctor

Other information

STORAGE AND HANDLING SECTION

• each softgel contains: sodium 7 mg. Very low sodium
• store at 59°-77°F (15°-25°C)
• keep tightly closed
• Tamper Evident: Do not use if imprinted seal
under cap is missing or broken.

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C red #40, FD&C yellow #6 (sunset yellow), gelatin, glycerin, PEG, sorbitol special, water.

HOW SUPPLIED

How Supplied Section

Docusate Sodium 100mg Capsule

  • NDC: 71335-0294-1: 30 Tablets in a BOTTLE
  • NDC: 71335-0294-2: 100 Tablets in a BOTTLE
  • NDC: 71335-0294-3: 60 Tablets in a BOTTLE
  • NDC: 71335-0294-4: 120 Tablets in a BOTTLE
  • NDC: 71335-0294-5: 90 Tablets in a BOTTLE
  • NDC: 71335-0294-6: 180 Tablets in a BOTTLE
  • NDC: 71335-0294-7: 10 Tablets in a BOTTLE
  • NDC: 71335-0294-8: 28 Tablets in a BOTTLE
  • NDC: 71335-0294-9: 56 Tablets in a BOTTLE
  • NDC: 71335-0294-0: 18 Tablets in a BOTTLE

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Docusate Sodium 100mg Capsule

Label
Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1115005docusate sodium 100 MG Oral CapsulePSN8
1115005docusate sodium 100 MG Oral CapsuleSCD8
1115005DOSS Sodium 100 MG Oral CapsuleSY8

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0294-0Stool Softener50 in 1 BOTTLECAPSULE, LIQUID FILLED508
71335-0294-1Stool Softener30 in 1 BOTTLECAPSULE, LIQUID FILLED308
71335-0294-2Stool Softener100 in 1 BOTTLECAPSULE, LIQUID FILLED1008
71335-0294-3Stool Softener60 in 1 BOTTLECAPSULE, LIQUID FILLED608
71335-0294-4Stool Softener120 in 1 BOTTLECAPSULE, LIQUID FILLED1208
71335-0294-5Stool Softener90 in 1 BOTTLECAPSULE, LIQUID FILLED908
71335-0294-6Stool Softener180 in 1 BOTTLECAPSULE, LIQUID FILLED1808
71335-0294-7Stool Softener10 in 1 BOTTLECAPSULE, LIQUID FILLED108
71335-0294-8Stool Softener28 in 1 BOTTLECAPSULE, LIQUID FILLED288
71335-0294-9Stool Softener56 in 1 BOTTLECAPSULE, LIQUID FILLED568

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0294STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BRYANT RANCH PREPACK]8Current NDC, Legacy NDC, 10 package rows20240707_2c9a1fe7-b77b-436b-8701-9f95f642d001.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0294-0EA - Each71335-02942a426e7c-5ba4-491b-a9f9-35da5ca1ef5012018-01-12
71335-0294-1EA - Each71335-02940814f62f-01a5-4830-bd48-a87f11ce9f2212018-01-12
71335-0294-2EA - Each71335-0294b3780648-4e65-4780-9b48-e7317c09a11412018-01-12
71335-0294-3EA - Each71335-02949b84ef75-60d3-4091-bf5b-729cb79396a212018-01-12
71335-0294-4EA - Each71335-0294b5c2d744-96ef-4712-90f6-2bb696766d7412018-01-12
71335-0294-5EA - Each71335-0294a00fd0e8-a544-491f-943b-7eef2511394c12018-01-12
71335-0294-6EA - Each71335-029489de2b53-630c-43d6-b5a0-a0d0e4defa7112018-01-12
71335-0294-7EA - Each71335-0294b40fa438-1b3e-4889-8e62-79e3b096278712018-01-12
71335-0294-8EA - Each71335-02943e62798c-1d9e-455f-b374-4b205309f38912018-01-12
71335-0294-9EA - Each71335-0294b24ea9eb-e2bf-4b8a-94db-f0bad33267ab12018-01-12
57896-401-01EA - Each57896-401da8e6844-b6ae-4244-8bfc-f7ad99d8eaf812013-06-04
57896-401-03EA - Each57896-4016762957d-d7f6-4213-a664-2c7f42fc9f3612013-06-04
57896-401-10EA - Each57896-4017ae1d03c-6162-4398-b8d2-1946db28e94112013-06-04
57896-401-20EA - Each57896-4018f701acd-94d7-43d2-9072-f8fbf72510af12021-02-05
57896-401-25EA - Each57896-4015c82cab7-f225-43ff-b3f5-38f5ffd4b01a12018-11-06

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71335-029471335-0294-1, 71335-0294-2, 71335-0294-3, 71335-0294-4, 71335-0294-5, 71335-0294-6, 71335-0294-7, 71335-0294-8, 71335-0294-9, 71335-0294-0
57896-401

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C RED NO. 40WZB9127XOAIACT
GELATIN, UNSPECIFIED2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool SoftenerDOCUSATE SODIUMBryant Ranch Prepack2c9a1fe7-b77b-436b-8701-9f95f642d0012024-07-05WarningsExact identifier
ndc (package): 71335-0294-9
ndc (package): 71335-0294-5
ndc (package): 71335-0294-7
ndc (package): 71335-0294-8
ndc (package): 71335-0294-2
ndc (package): 71335-0294-4
ndc (package): 71335-0294-6
ndc (package): 71335-0294-3
ndc (package): 71335-0294-0
ndc (package): 71335-0294-1
ndc (product): 71335-0294
ndc11 (package): 71335029400
ndc11 (package): 71335029402
ndc11 (package): 71335029403
ndc11 (package): 71335029401
ndc11 (package): 71335029405
ndc11 (package): 71335029404
ndc11 (package): 71335029408
ndc11 (package): 71335029406
ndc11 (package): 71335029407
ndc11 (package): 71335029409
spl id: 982de9ab-1968-4284-9dd9-1d05bf048fde
spl set id: 2c9a1fe7-b77b-436b-8701-9f95f642d001
Stool SoftenerDOCUSATE SODIUMGeri-Care Pharmaceutical Corp644d81ec-d38f-4172-a087-727b94e2fefe2023-10-19WarningsExact identifier
ndc (product): 57896-401

Reported adverse events (FAERS/openFDA)#

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