FDA.reportPublic FDA data

Docu Liquid

Manufacturer
Cardinal Health 107, LLC
Effective date
2023-11-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:20:30

Label at a glance#

ProductDocu Liquid
Active ingredientDOCUSATE SODIUM
Label structure9 sections

Indications and uses

• relieves occasional constipation • generally produces bowel movement in 12-72

Dosage and administration

• may be taken once daily or in divided doses • give dose in 1/2 glass of milk, fruit juice or infant formula to mask bitter taste and prevent throat irritation adults and children over 12 1 to 7 teaspoons children 2 to under 12 1 to 3 teaspoons children under 2 ask a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 50 mg

Purpose

OTC - PURPOSE SECTION

Stool Softener Laxative

Uses

INDICATIONS & USAGE SECTION

  • relieves occasional constipation
  • generally produces bowel movement in 12-72

Warnings

WARNINGS SECTION

Do Not Use

OTC - DO NOT USE SECTION

  • if you are presently taking mineral oil
  • when abdominal pain, nausea, or vomiting are present
  • for longer than one week

Ask a doctor before use if you have

SPL UNCLASSIFIED SECTION

noticed a sudden change in bowel habits that lasts over two weeks.

Ask a doctor or pharmacist before use if you are

SPL UNCLASSIFIED SECTION

taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Stop use and ask a doctor if

SPL UNCLASSIFIED SECTION

  • you have rectal bleeding
  • you fail to have a bowel movement after use of this product

These may indicate a serious condition.

If pregnant or breast-feeding,

SPL UNCLASSIFIED SECTION

ask a health professional before use.

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • may be taken once daily or in divided doses
  • give dose in 1/2 glass of milk, fruit juice or infant formula to mask bitter taste and prevent throat irritation

adults and children over 12

1 to 7 teaspoons

children 2 to under 12

1 to 3 teaspoons

children under 2

ask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • each teaspoon contains: sodium 5 mg
  • shake well before using
  • store at controlled room temperature 15° - 30°C (59° - 86°F)
  • dispense contents with a child resistant closure in a tight, light resistant container as defined in the USP
  • store in an upright position

Inactive Ingredients

INACTIVE INGREDIENT SECTION

D&C Red #33, methylparaben, natural & artificial vanilla flavor, poloxamer 181, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium benzoate. Sodium citrate may be used to adjust pH.

Questions or comments?

SPL UNCLASSIFIED SECTION

  • Call 1-800-932-5676

Mon - Thurs. 9:00 am - 4:30 pm EST, Fri. 9:00 am - 2:30 pm EST.

Serious side effects associated with use of this product may be reported to this number.

Distributed By:

Cardinal Health

Dublin, OH 43017

L57365410522

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DOCU LIQUID

(DOCUSATE SODIUM)

100 mg/ 10 mL

STOOL SOFTENER LAXATIVE

5 Cups

bag label
bag label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-349-10ML - Milliliter50383-349b04e14fb-0732-4d09-8963-56e894cc568312021-07-15
50383-349-11ML - Milliliter50383-3492b1627ec-43db-4e48-962a-02e845d117a212021-07-15

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55154-963055154-9630-5
50383-349

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
DOCUSATE SODIUMF05Q2T2JA0ACTIB
D&C RED NO. 339DBA0SBB0LIACT
METHYLPARABENA2I8C7HI9TIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
WATER059QF0KO0RIACT
POLOXAMER 18109Y8E6164AIACT

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
4aa45174-971a-484e-a089-d6c203e967e4931430a0-202a-4296-a2ad-6bf4e5919b612024-08-29WarningsExact identifier
spl set id: 931430a0-202a-4296-a2ad-6bf4e5919b61

Reported adverse events (FAERS/openFDA)#

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