Indications and uses
relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours
Docusate Sodium
- Manufacturer
- McKesson Corporation dba SKY Packaging
- Effective date
- 2025-01-22
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 17
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 20:40:46
Label at a glance#
ProductDocusate Sodium
Active ingredientDOCUSATE SODIUM
Label structure11 sections
Dosage and administration
Dose once daily take with 6 to 8 oz of milk, juice or infant formula to mask the bitter taste. adults and children 12 years and older 5 to 20 mL (1 to 4 teaspoonfuls) children 6 to under 12 years of age 5 to 10 mL (1 to 2 teaspoonfuls) children 3 to under 6 years of age 2.5 to 5 mL (1/2 to 1 teaspoonful) children under 3 years ask a doctor
Storage and handling
• Sodium content: 14 mg/ 5 mL • Store at controlled room temperature, 20° to 25°C (68° to 77°F) • Protect from freezing • Protect from light • Clear pink to purple-pink colored, cherry flavored liquid supplied in the following: NDC 63739-976-01: 10 mL Unit Dose Cup NDC 637369-976-10: 1 case of 100 x 10 mL Unit Dose Cups
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each 10 mL)
Docusate sodium 100 mg
Purpose
Stool softener
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 12 to 72 hours
Warnings
Do not use
- if you are presently taking mineral oil, unless told to do so by a doctor
Ask a doctor before use if you have
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that lasts over 2 weeks
Stop use and ask a doctor if
- you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
- you need to use a stool softener laxative for more than 1 week
- rash occurs
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
- Dose once daily
- take with 6 to 8 oz of milk, juice or infant formula to mask the bitter taste.
| adults and children 12 years and older | 5 to 20 mL (1 to 4 teaspoonfuls) |
| children 6 to under 12 years of age | 5 to 10 mL (1 to 2 teaspoonfuls) |
| children 3 to under 6 years of age | 2.5 to 5 mL (1/2 to 1 teaspoonful) |
| children under 3 years | ask a doctor |
Other information
- • Sodium content: 14 mg/ 5 mL
• Store at controlled room temperature, 20° to 25°C (68° to 77°F)
• Protect from freezing
• Protect from light
• Clear pink to purple-pink colored, cherry flavored liquid supplied in the following:
NDC 63739-976-01: 10 mL Unit Dose Cup
NDC 637369-976-10: 1 case of 100 x 10 mL Unit Dose Cups
Inactive ingredients
artificial cherry vanilla flavoring, citric acid anhydrous, D&C Red No. 33, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, saccharin sodium, sodium citrate, and sorbitol.
Questions or comments?
Call 1-800-845-8210
SPL UNCLASSIFIED SECTION
DISTRIBUTIONED BY
SKY/McKesson Corporation
dba SKY Packaging
Memphis, TN 38141
PRINCIPAL DISPLAY PANEL - 10 mL Cup Tray Label
Delivers 10 mL
NDC 63739-976-01
Docusate Sodium Liquid
100 mg/ 10 mL
STOOL SOFTENER LAXATIVE
Alcohol Free/Sugar Free
FOR INSTITUTIONAL USE ONLY
Dist. by: SKY Packaging
Memphis, TN 38141
SEE DRUG FACTS
F0935C101022
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63739-976-01 | ML - Milliliter | 63739-976 | 8b9e3737-2e97-4a4d-a7b6-60bb4d07445b | 1 | 2024-05-16 |
| 63739-976-10 | ML - Milliliter | 63739-976 | 754269d0-c894-420f-aefa-413aaa153846 | 1 | 2024-02-14 |
| 0121-0935-05 | ML - Milliliter | 0121-0935 | bd4be1fb-4d63-4e7c-8bfa-2e34cd4de1c5 | 1 | 2021-10-08 |
| 0121-0935-16 | ML - Milliliter | 0121-0935 | 3bdd2684-e7df-4efc-abb2-b74bbcf7d516 | 1 | 2021-10-08 |
| 0121-0935-40 | ML - Milliliter | 0121-0935 | 3327600b-3340-46f6-b2a4-f6be1a4545bb | 1 | 2021-10-08 |
Products#
Every source-derived product name is available through these pages.
- Docusate Sodium
- DOCUSATE
- ANHYDROUS CITRIC ACID
- D&C RED NO. 33
- GLYCERIN
- METHYLPARABEN
- PROPYLENE GLYCOL
- PROPYLPARABEN
- WATER
- SODIUM CITRATE
- SACCHARIN SODIUM
- SORBITOL SOLUTION
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63739-976 | 63739-976-01, 63739-976-10 |
| 0121-0935 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DOCUSATE SODIUM | F05Q2T2JA0 | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| D&C RED NO. 33 | 9DBA0SBB0L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SORBITOL SOLUTION | 8KW3E207O2 | 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 | DOCUSATE SODIUM | PAI Holdings, LLC dba PAI Pharma | e975a3f1-0e1f-4fb8-9c5f-baa75e12f2a5 | 2025-02-06 | Warnings | 0121-0935 |
| 63c976ab-13e7-4634-adb0-d22476ec6289 | 557d0f60-9e4b-418e-8a8b-dd93bdf994e2 | 2025-01-22 | Warnings | 63c976ab-13e7-4634-adb0-d22476ec6289 557d0f60-9e4b-418e-8a8b-dd93bdf994e2 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.