Silace

Manufacturer
Carilion Materials Management
Effective date
2017-12-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:53:50

Label at a glance#

ProductSilace
Active ingredientDOCUSATE SODIUM
Label structure14 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 years
50 to 200 mg (1 to 4 teaspoonful)
Children 6 to under 12 years
50 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 age
Ask 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

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 68151-0116

NDC: 68151-0116-1 1 mL in a CUP, UNIT-DOSE

SILACE (DOCUSATE SODIUM) LIQUID

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68151-0116-12020-01-31C16284748780-19d75b9d0-43b1-f424-e053-dadaa90a57ceSilace Liquid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-0116-1Silace1 mL in 1 CUP, UNIT-DOSELIQUID12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-0116SILACE (DOCUSATE SODIUM) LIQUID [CARILION MATERIALS MANAGEMENT]2Legacy NDC, 1 package rows20171229_6e995a27-e841-4c7f-bcb1-b2f5ef25d9e6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
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
68151-011668151-0116-1
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
974b3e52-3710-498b-8d59-d96491d23b9c6e995a27-e841-4c7f-bcb1-b2f5ef25d9e62017-12-28WarningsExact identifier
spl id: 974b3e52-3710-498b-8d59-d96491d23b9c
spl set id: 6e995a27-e841-4c7f-bcb1-b2f5ef25d9e6

Reported adverse events (FAERS/openFDA)#

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