Silace

Manufacturer
ATLANTIC BIOLOGICALS CORP.
Effective date
2016-10-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:47:47

Label at a glance#

ProductSilace
Active ingredientDocusate sodium
Label structure13 sections

Indications and uses

for gentle, reliable relief from occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours

Dosage and administration

take as indicated by doctor this product must be given in a 6 to 8 oz. glass of milk or fruit juice or infant's formula to prevent throat irritation. Dose may be taken as a single daily dose or in divided doses dosage should be adjusted to individual response higher doses are recommended for initial therapy the effect on stools is usually apparent 1 to 3 days after the first dose Adults and children over 12 years ...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Docusate sodium 10 mg (in each 1 mL)

OTC - PURPOSE SECTION

Purpose: Stool Softener

Uses

INDICATIONS & USAGE SECTION

  • for gentle, reliable relief from occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours

Warning

WARNINGS SECTION

  • Do not use laxative products for longer than 1 week unless told to do so by a doctor
  • if you are presently taking mineral oil unless told to do by a doctor

OTC - ASK DOCTOR SECTION

Ask doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that last over two weeks

OTC - STOP USE SECTION

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

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

  • take as indicated by doctor
  • this product must be given in a 6 to 8 oz. glass of milk or fruit juice or infant's formula to prevent throat irritation. Dose may be taken as a single daily dose or in divided doses
  • dosage should be adjusted to individual response
  • higher doses are recommended for initial therapy
  • the effect on stools is usually apparent 1 to 3 days after the first dose
Adults and children over 12 years50 to 200 mg (1 to 4 teaspoonful)
Children 6 to under 12 years50 to 100 mg (1 to 2 teaspoonful)
Children 3 to under 6 years25 to 50 mg(1/2 to 1 teaspoonful)
Children under 3 years of ageAsk a doctor

Other information

SPL UNCLASSIFIED SECTION

  • store at room temperature 20°-25°C (68°-77°F)
  • protect from freezing and excessive heat
  • do not use if tamperevident safety seal around cap is broken or missing
  • dispense in tight, light-resistant container with a child-resistant closure

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, D&C red no. 33, flavor, methylparaben, Poloxamer, propylene glycol, propylparaben, purified water, sodium citrate.

OTC - QUESTIONS SECTION

Questions

888-974-5279

This product is not manufactured or distributed by Purdue Products LP, distributor of Colace® Liquid.

Manufactured by:

Silarx Pharmaceuticals, Inc.
1033 Stoneleigh Ave
Carmel, NY 10512
USA

17856-0116-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1245686docusate sodium 50 MG in 5 mL Oral SolutionPSN3
1245686docusate sodium 10 MG/ML Oral SolutionSCD3
1245686docusate sodium 10 MG per 1 ML Oral SolutionSY3
1245686docusate sodium 100 MG per 10 ML Oral SolutionSY3
1245686docusate sodium 150 MG per 15 ML Oral SolutionSY3
1245686DOSS Sodium 10 MG/ML Oral SolutionSY3

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 1281785601160217856-0116 box labela.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0116-22020-01-31C16284748780-19d75b9d1-1134-f424-e053-dadaa90a57ceSilace Liquid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0116-2Silace25 mL in 1 CUPLIQUID253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0116SILACE (DOCUSATE SODIUM) LIQUID [ATLANTIC BIOLOGICALS CORP.]3Legacy NDC, 1 package rows20161026_b70aabb5-8b56-40ee-b46e-7eca3bf0bbe4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0116-2ML - Milliliter17856-0116019eaacd-2690-4bcf-9763-a86ded5694e212016-11-08
54838-116-80ML - Milliliter54838-1168ad43c4d-ee45-4427-bc78-e543e668675912012-07-24

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
17856-011617856-0116-2
54838-116

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
1a663219-308a-4d3a-acfa-bb5ef9dc3fffb70aabb5-8b56-40ee-b46e-7eca3bf0bbe42016-10-26WarningsExact identifier
spl id: 1a663219-308a-4d3a-acfa-bb5ef9dc3fff
spl set id: b70aabb5-8b56-40ee-b46e-7eca3bf0bbe4

Reported adverse events (FAERS/openFDA)#

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