Stool Softener Liquid

Manufacturer
ATLANTIC BIOLOGICALS CORP.
Effective date
2021-01-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:37:02

Label at a glance#

ProductStool Softener Liquid
Active ingredientDOCUSATE SODIUM
Label structure10 sections

Indications and uses

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

Dosage and administration

follow dosing directions below or take as directed by doctor must be given in a 6 to 8 oz glass of milk or fruit juice to prevent throat irritation may be taken as a single daily dose or in divided doses take maximum daily dose until first bowel movement, then reduce dose according to individual response shake well before using Adults and children 12 years and over 1 to 4 teaspoonfuls (5 to 20 mL) Children under 1...

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL teaspoonful)

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 50 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 for more than one week unless directed by a doctor

Ask a doctor before use if you

  • have abdominal pain, nausea, or vomiting
  • are taking mineral oil
  • have noticed a sudden change in bowel habits that lasts more than 14 days

Stop use and ask a doctor if

  • you have rectal bleeding or failure to have a bowel movement within 3 days. These could be signs of a serious condition.
  • a skin rash occurs
  • you experience throat irritation

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

  • follow dosing directions below or take as directed by doctor
  • must be given in a 6 to 8 oz glass of milk or fruit juice to prevent throat irritation
  • may be taken as a single daily dose or in divided doses
  • take maximum daily dose until first bowel movement, then reduce dose according to individual response
  • shake well before using
Adults and children 12 years and over
1 to 4 teaspoonfuls (5 to 20 mL)
Children under 12 years of age
ask a doctor

Other information

OTHER SAFETY INFORMATION

  • Each teaspoonful contains: sodium 15 mg
  • Store at room temperature 15°- 30° C (59°-86° F)
  • protect from excessive heat
  • Keep tightly closed

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, D&C Red #33, flavor, parabens, poloxamer, polyethylene glycol, sodium citrate, sorbitol, sucrose, and water.

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

20101 N.E 16TH PLACE 

MIAMI, FL 33179

package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 17856-0398-1

Compare to Colace® Liquid active ingredient *

GOOD NEIGHBOR PHARMACY

STOOL
SOFTENER
LIQUID
Docusate Sodium
Relieves Constipation
250mg/25 mL 

50 cups per case

image 1image 1

NDC 17856-0398-2

Compare to Colace® Liquid active ingredient *

GOOD NEIGHBOR PHARMACY

STOOL
SOFTENER
LIQUID
Docusate Sodium
Relieves Constipation
100mg/10 mL

72 cups per case

image 2image 2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1245686docusate sodium 50 MG in 5 mL Oral SolutionPSN2
1245686docusate sodium 10 MG/ML Oral SolutionSCD2
1245686docusate sodium 10 MG per 1 ML Oral SolutionSY2
1245686docusate sodium 100 MG per 10 ML Oral SolutionSY2
1245686docusate sodium 150 MG per 15 ML Oral SolutionSY2
1245686DOSS Sodium 10 MG/ML Oral SolutionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0398-12023-01-30C16284748780-1f386c649-be54-0266-e053-dadaa90a7c1aGNP DOCUSATE LIQUID
17856-0398-22023-01-30C16284748780-1f386c649-be54-0266-e053-dadaa90a7c1aGNP DOCUSATE LIQUID

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0398-1Stool Softener Liquid50 in 1 BOX, UNIT-DOSELIQUID502
17856-0398-1Stool Softener Liquid25 mL in 1 CUP, UNIT-DOSELIQUID252
17856-0398-2Stool Softener Liquid10 mL in 1 CUP, UNIT-DOSELIQUID102
17856-0398-2Stool Softener Liquid72 in 1 BOX, UNIT-DOSELIQUID722

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0398STOOL SOFTENER LIQUID (DOCUSATE SODIUM) LIQUID [ATLANTIC BIOLOGICALS CORP.]2Legacy NDC, 4 package rows20210119_3bcab14d-a4b2-433a-9d1f-5dec61c7ae24.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-399-43ML - Milliliter46122-399ed36e0c1-aabc-437a-81d3-da0f88d169ed12018-03-08

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
17856-039817856-0398-1, 17856-0398-2
46122-399

Ingredients#

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

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

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
42953e6a-873c-4c32-afa7-94196611cc1c3bcab14d-a4b2-433a-9d1f-5dec61c7ae242021-01-18WarningsExact identifier
spl id: 42953e6a-873c-4c32-afa7-94196611cc1c
spl set id: 3bcab14d-a4b2-433a-9d1f-5dec61c7ae24

Reported adverse events (FAERS/openFDA)#

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