Docusate Sodium
e975a3f1-0e1f-4fb8-9c5f-baa75e12f2a5
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts
Purpose
Stool softener
Medication Information
Purpose
Stool softener
Description
Drug Facts
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 12 to 72 hours
Section 42229-5
Drug Facts
Section 50565-1
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Section 53414-9
If pregnant or breast-feeding, ask a health professional before use.
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 |
Do Not Use
- if you are presently taking mineral oil, unless told to do so by 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 0121-0935-16: 16 fl oz (473 mL) bottle
NDC 0121-0935-05: 5 mL unit dose cup, in a tray of ten cups.
NDC 0121-1870-10: 10 mL unit dose cup, in a tray of ten 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
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
Active Ingredient (in Each 5 Ml)
Docusate sodium 50 mg
Ask A Doctor Before Use If You Have
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that lasts over 2 weeks
Principal Display Panel 5 Ml Cup Lidding
NDC 0121-0935-05
Docusate Sodium Liquid
50 mg/5 mL
STOOL SOFTENER LAXATIVE
Alcohol Free/Sugar Free
Package Not Child-Resistant
Pharmaceutical Associates, Inc.
Greenville, SC 29605
Principal Display Panel 10 Ml Cup Lidding
NDC 0121-1870-10
Docusate Sodium Liquid
100 mg/10 mL
STOOL SOFTENER LAXATIVE
Alcohol Free/Sugar Free
Package Not Child-Resistant
Pharmaceutical Associates, Inc.
Greenville, SC 29605
Principal Display Panel 16 Fl Oz (473 Ml)
NDC 0121-0935-16
Docusate Sodium Liquid
50 mg/5 mL
STOOL SOFTENER LAXATIVE
Alcohol Free/Sugar Free
16 fl oz (473 mL)
Pharmaceutical Associates, Inc.
Greenville, SC 29605
X0935160721 R07/21
Structured Label Content
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 12 to 72 hours
Section 42229-5 (42229-5)
Drug Facts
Section 50565-1 (50565-1)
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use.
Purpose
Stool softener
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 |
Do Not Use (Do not use)
- if you are presently taking mineral oil, unless told to do so by a doctor
Other Information (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 0121-0935-16: 16 fl oz (473 mL) bottle
NDC 0121-0935-05: 5 mL unit dose cup, in a tray of ten cups.
NDC 0121-1870-10: 10 mL unit dose cup, in a tray of ten cups.
Inactive Ingredients (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? (Questions or comments?)
Call 1-800-845-8210
Stop Use and Ask A Doctor If (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
Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))
Docusate sodium 50 mg
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that lasts over 2 weeks
Principal Display Panel 5 Ml Cup Lidding (PRINCIPAL DISPLAY PANEL - 5 mL Cup LIdding)
NDC 0121-0935-05
Docusate Sodium Liquid
50 mg/5 mL
STOOL SOFTENER LAXATIVE
Alcohol Free/Sugar Free
Package Not Child-Resistant
Pharmaceutical Associates, Inc.
Greenville, SC 29605
Principal Display Panel 10 Ml Cup Lidding (PRINCIPAL DISPLAY PANEL - 10 mL Cup Lidding)
NDC 0121-1870-10
Docusate Sodium Liquid
100 mg/10 mL
STOOL SOFTENER LAXATIVE
Alcohol Free/Sugar Free
Package Not Child-Resistant
Pharmaceutical Associates, Inc.
Greenville, SC 29605
Principal Display Panel 16 Fl Oz (473 Ml) (PRINCIPAL DISPLAY PANEL - 16 fl oz (473 ML))
NDC 0121-0935-16
Docusate Sodium Liquid
50 mg/5 mL
STOOL SOFTENER LAXATIVE
Alcohol Free/Sugar Free
16 fl oz (473 mL)
Pharmaceutical Associates, Inc.
Greenville, SC 29605
X0935160721 R07/21
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:05:34.320519 · Updated: 2026-03-14T23:07:34.278056