Silace syrup

Manufacturer
Bryant Ranch Prepack
Effective date
2019-08-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:15:13

Label at a glance#

ProductSilace
Active ingredientDOCUSATE SODIUM
Label structure14 sections

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Docusate sodium 60 mg (in each 15 mL (1 tablespoonful))

OTC - PURPOSE SECTION

Purpose: Stool Softener

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

Warnings

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

OTC - ASK DOCTOR SECTION

Ask a 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.

DOSAGE & ADMINISTRATION SECTION


Directions

  • take as directed by a doctor
  • doses must be given in a 6-8 oz glass of milk or fruit juice, to prevent throat irritation
  • dose may be taken as a single daily dose or in divided doses
  • dosage should be adjusted to individual response

 Adults and children 12 years of age and older
 1 to 6 tablespoonfuls, or as directed by a doctor
 Children 6 to under 12 years of age
 1 to 2 1/2 tablespoonfuls, or as directed by a doctor
 Children under 6 years
 Ask a doctor

STORAGE AND HANDLING SECTION

Other information

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

INACTIVE INGREDIENT SECTION

Inactive ingredients:

alcohol not more than 1%, citric acid, D&C red no. 33, FD&C red no. 40, peppermint flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium benzoate, sodium citrate, sucrose.

OTC - QUESTIONS SECTION

Questions

888-974-5279

SPL UNCLASSIFIED SECTION

Manufactured by:

Silarx Pharmaceutical, Inc.

1033 Stoneleigh Ave

Carmel , NY 10512-USA.

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 63629-1807

NDC: 63629-1807-1 240 mL in a BOTTLE

NDC: 63629-1807-2 120 mL in a BOTTLE

docusate Sodium Syrup 20mg/5ML

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1807-2ML - Milliliter63629-1807462361fd-b515-408f-9e83-cb680b265a5f12017-06-15
54838-107-80ML - Milliliter54838-107969d0f08-3349-4be9-94f1-c15fa7bafbae12012-07-24

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63629-180763629-1807-1, 63629-1807-2
54838-107

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
8b99a145-bfbe-4cd5-a68e-26d2f36f990a465209b9-bf2a-4cde-8cee-5181b9502deb2021-11-10WarningsExact identifier
spl set id: 465209b9-bf2a-4cde-8cee-5181b9502deb

Reported adverse events (FAERS/openFDA)#

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