GC DOCUSATE SYRUP

Manufacturer
GERI-CARE PHARMACEUTICAL CORP
Effective date
2019-12-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:50:25

Label at a glance#

ProductDIOCTO
Active ingredientDOCUSATE SODIUM
Label structure10 sections

Indications and uses

prevents / relieves dry hard stool results usually occur 1 to 3 days after the first dose

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 do not exceed recommended dose shake well before using Adults and children 12 years and over 1 to 3 tablespoons...

Label contents#

Full prescribing information#

Active ingredient (per tablespoon = 15mL)

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 60 mg

Purpose

OTC - PURPOSE SECTION

Stool Softener

Uses

INDICATIONS & USAGE SECTION

  • prevents / relieves dry hard stool
  • results usually occur 1 to 3 days after the first dose

Warnings

WARNINGS SECTION

Do not use

  • when abdominal pain, nausea, or vomiting are present
  • for more than one week unless directed by a doctor

Ask a doctor before use if you

  • ​are taking mineral oil
  • have noticed a sudden change in bowel habits that lasts more than 2 weeks

Stop use and ask a doctor if

  • you have no bowel movement within 3 days
  • you have rectal bleeding
  • 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 accidental overdose, seek professional assistance or contact a Poison Control Center immediately

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
  • do not exceed recommended dose
    • shake well before using
Adults and children 12 years and over1 to 3 tablespoons
Children under 12 years of ageask a doctor

1 tablespoon = 15 mL

Other information

OTHER SAFETY INFORMATION

  • Store at room temperature 15 - 30 C (59 -86 F)
  • protect from excessive heat
  • Keep tightly closed
  • Dispense in tight, light resistant container as defined in the USP
  • For institutional use only
  • Each teaspoon (5 mL) contains sodium: 14mg.

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, D&C Red #33, FD&C Red#40, flavors, glycerin, propylene glycol, water, sodium citrate, sodium saccharin, sodium benzoate, sorbitol.

package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

409409

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-409-16ML - Milliliter57896-409debfddae-e526-4bbd-b515-5fffc2d2b3bb12018-06-11

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57896-40957896-409-16

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
9a008b9f-5dc6-fac0-e053-2995a90a17c66bcc15ee-c588-bf48-e053-2991aa0aca172019-12-18WarningsExact identifier
spl id: 9a008b9f-5dc6-fac0-e053-2995a90a17c6
spl set id: 6bcc15ee-c588-bf48-e053-2991aa0aca17

Reported adverse events (FAERS/openFDA)#

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