Stool Softener Syrup

Manufacturer
AMERISOURCEBERGEN DRUG CORPORATION | 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 23:50:22

Label at a glance#

ProductStool Softener Syrup
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 3 tablespoonfuls (15 to 45 mL) Children unde...

Label contents#

Full prescribing information#

Active ingredient (in each 15 mL tablespoonful)

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 60 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
  • have a sodium-restricted diet

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 over1 to 3 tablespoonfuls (15 to 45 mL)
Children under 12 years of ageask a doctor

Other information

OTHER SAFETY INFORMATION

  • Each 15 mL tablespoonful contains: sodium 51 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, FD&C Red #40, flavors, glycerin, propylene glycol, sodium benzoate, sodium citrate, sodium saccharin, sorbitol, water.

package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 46122-400-43

Compare to Colace® Syrup active ingredient *

GOOD NEIGHBOR PHARMACY

STOOL
SOFTENER
SYRUP
Docusate Sodium
Relieves Constipation
60 mg/15 mL
16 FL OZ (473 mL)

colace syrupcolace syrup

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-400-43ML - Milliliter46122-4005d54269e-3269-428d-92bb-ae5d9c8dc00212018-03-08

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
46122-40046122-400-43

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 · Source PDF

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
9a008b17-f1e0-ba0c-e053-2a95a90a2c905bc084e8-13d2-ae6c-e053-2991aa0af40b2019-12-18WarningsExact identifier
spl id: 9a008b17-f1e0-ba0c-e053-2a95a90a2c90
spl set id: 5bc084e8-13d2-ae6c-e053-2991aa0af40b

Reported adverse events (FAERS/openFDA)#

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