Docusate Sodium Liquid
- Manufacturer
- LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
- Effective date
- 2025-12-31
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 9
- Source
- full-release
- Hydrated at
- 2026-06-01 01:30:03
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients (per 5 mL)
Docusate Sodium 50 mg
OTC - PURPOSE SECTION
Purpose
Stool Softener
INDICATIONS & USAGE SECTION
Uses
Relief of occasional constipation
WARNINGS SECTION
Warnings
Do not use when
- abdominal pain, nausea, or vomiting are present unless directed by a doctor
- for more than one week unless directed by a doctor
Ask a doctore before use if you
- are taking mineral oil
- have noticed a sudden change in bowel habits that last more than two weeks
Stop use and ask doctor if
- you have no bowel movements 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 doctor before use
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of accidental overdose, seek medical assistance or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions
- follow dosing directions below or use as directed by a physician
- must be given in a 6 oz to 8 oz glass of milk 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 then be reduced according to individual response
- do not exceed recommended dose
- shake well before using
1 teasponnful = 5 mL
| Age | Dose |
| Adults and children over 12 years of age | 1 to 6 teaspoons (50 mg - 300 mg) |
| Children under 12 years of age | Ask a doctor |
INACTIVE INGREDIENT SECTION
Inactive ingredients: FD&C red #40, flavor, methylparaben, poloxamer, polyethylene glycol, propylene glycol, propylparaben, sodium benzoate, sodium citrate, sucralose
OTC - QUESTIONS SECTION
Questions or comments? 1-866-595-5598
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1248119 | docusate sodium 50 MG in 5 mL Oral Suspension | PSN | 9 |
| 1248119 | docusate sodium 10 MG/ML Oral Suspension | SCD | 9 |
| 1248119 | docusate sodium 100 MG per 10 ML Oral Suspension | SY | 9 |
| 1248119 | docusate sodium 150 MG per 15 ML Oral Suspension | SY | 9 |
| 1248119 | docusate sodium 50 MG per 5 ML Oral Suspension | SY | 9 |
| 1248119 | DOSS Sodium 10 MG/ML Oral Suspension | SY | 9 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54859-813-16 | Docusate Sodium Liquid | 473 mL in 1 BOTTLE | LIQUID | 473 | 9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 54859-813-16 | ML - Milliliter | 54859-813 | 25502fa9-6f5b-4d15-898f-034a45e4599b | 1 | 2025-05-14 |
Products#
Every source-derived product name is available through these pages.
- Docusate Sodium Liquid
- Docusate Sodium
- WATER
- SODIUM BENZOATE
- SODIUM CITRATE
- SUCRALOSE
- DOCUSATE
- FD&C RED NO. 40
- METHYLPARABEN
- POLOXAMER 124
- POLYETHYLENE GLYCOL, UNSPECIFIED
- PROPYLENE GLYCOL
- PROPYLPARABEN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 54859-813 | 54859-813-16 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| DOCUSATE SODIUM | F05Q2T2JA0 | ACTIB |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| POLOXAMER 124 | 1S66E28KXA | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Docusate Sodium Liquid | DOCUSATE SODIUM | LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION | 2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41c | 2025-12-31 | Warnings | 54859-813-16 54859-813 54859081316 4745fe35-8aba-b427-e063-6394a90ab073 2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
