Docusate Sodium Liquid

Manufacturer
Aldama Pharmaceuticals, Inc
Effective date
2026-08-10
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
daily-update
Hydrated at
2026-08-12 01:01:01

Label at a glance#

ProductDocusate Sodium Liquid
Active ingredientDOCUSATE SODIUM
Label structure14 sections

Indications and uses

Relief of occasional constipation

Dosage and administration

follow dosing directions below or use as directed by a physician must be give in a 6 oz to 8 oz glass of mil or fruit juice to prevent throat irritation may be taken as a single daily dose or in dividend dose take maximum dose daily until first bowel movement dosage should the be reduced according to individual response do not exceed recommende dose shake well before using

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL-teaspoonful)

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 50mg

Purpose

OTC - PURPOSE SECTION

Stool Softener

Uses

INDICATIONS & USAGE SECTION

  • Relief of occasional constipation

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you

OTC - ASK DOCTOR SECTION

  • are taking mineral oil
  • have noticed a sudden change in bowel habits that last more than two weeks

Stop use and ask a doctor if

OTC - ASK DOCTOR/PHARMACIST SECTION

  • you have no bowel movements withing 3 days
  • you have rectal bleeding
  • these could be signs of a seriuos condition
  • a skin rash occurs
  • you experience throat irritation

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a doctor before use

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, seek medical assistance or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • follow dosing directions below or use as directed by a physician
  • must be give in a 6 oz to 8 oz glass of mil or fruit juice to prevent throat irritation
  • may be taken as a single daily dose or in dividend dose
  • take maximum dose daily until first bowel movement dosage should the be reduced according to individual response
  • do not exceed recommende dose
  • shake well before using

Other information

OTHER SAFETY INFORMATION

  • TAMPER EVIDENT: Do not use if foil seal over bottle opening is torn, broken or missing
  • store at room temperature between 20-25°C (68-77°F)
  • Permitted excursions between 15-30°C (59-86°F)
  • protect from excessive heat
  • Pharmacist:: preserve and dispense in a tight light, light-resistant container with a child-resistant cap as defined in the UPS
  • each teaspoon (5ml) contains sodium 5 mg

Inactive Ingredient

INACTIVE INGREDIENT SECTION

flavor, methylparaben, poloxamer, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium benzoate, sodium citrate and sucralose

Question or Comments?

OTC - QUESTIONS SECTION

305-592-9216 or info@aldamapharm.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

Products#

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DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73564-81373564-813-16

Ingredients#

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

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

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32026-07-01weekly-update2026-07-17 21:42:24
22026-05-15daily-update2026-06-03 18:04:04
12026-01-24full-release2026-06-01 01:34:56

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
Docusate Sodium LiquidDOCUSATE SODIUM.50MG/5MLAldama Pharmaceuticals, Inc492b6d37-47cf-3a28-e063-6294a90a2a182026-08-10WarningsExact identifier
ndc (package): 73564-813-16
ndc (product): 73564-813
ndc11 (package): 73564081316
spl id: 58b4cbbb-02dd-b19e-e063-6394a90a9e70
spl set id: 492b6d37-47cf-3a28-e063-6294a90a2a18

Reported adverse events (FAERS/openFDA)#

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