Active Ingredient (In Each 10 Ml Cup)
Docusate sodium 100 mg
Docusate Sodium Liquid
FDA Label NDC 60687-878
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by American Health Packaging for the product Docusate Sodium (NDC 60687-878). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each 10 ml cup), purpose, uses, do not use, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Stool softener
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 12 to 72 hours
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
If Pregnant Or Breast-Feeding,
ask a health professional before use.
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: 28 mg / 10 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-vanilla flavored liquid supplied in the following:
10 mL unit dose cups: 100 cups (10 x 10) NDC 60687-878-56
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
DO NOT USE IF SEAL IS BROKEN.
Distributed By:
American Health Packaging
Columbus, OH 43217
R12/24
Principal Display Panel – Tray Label
Case NDC 60687-878-56/Cup NDC 60687-878-42
Docusate Sodium Liquid
100 mg/10 mL
STOOL SOFTENER LAXATIVE
Alcohol Free/Sugar Free
USUAL DOSAGE: See attached Drug Facts
Store at 20° to 25°C (68° to 77°F)
[See USP Controlled Room Temperature].
For Institutional Use Only
T0935C101224 R12/24
Principal Display Panel – Cup – 100 Mg / 10 Ml
NDC 60687- 878-42
Docusate Sodium
Liquid
Stool Softener Laxative
100 mg/10 mL
Alcohol Free/Sugar Free
Delivers 10 mL
Protect from freezing. Protect from light.
See package Drug Facts insert for full
prescribing information and storage.
For Institutional Use Only.
American Health Packaging
Columbus, OH 43217
F0935C100125
* Please review the disclaimer below.
