Active Ingredient (In Each Softgel)
Docusate Sodium 100 mg
Docusate Sodium Capsule, Liquid Filled
FDA Label NDC 60687-129
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 60687-129). 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 softgel), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Stool softener laxative
Uses
- for relief of occasional constipation (irregularity)
- generally produces a bowel movement within 12 to 72 hours
Warnings
Do not use
- if you are currently taking mineral oil, unless directed by a doctor
- when abdominal pain, nausea or vomiting are present unless directed by a doctor
- for longer than one week unless directed by a doctor
Ask a doctor before use if you notice a sudden change in bowel habits that persists over a period of 2 weeks.
Stop use and ask a doctor if you have rectal bleeding or you fail to have a bowel movement after use of a laxative. This may indicate a serious condition.
If pregnant or breast-feeding, ask a health care professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
Take only by mouth. Doses may be taken as a single daily dose or in divided doses.
adults and children 12 years of age and over | take 1 to 3 softgels daily |
children 2 to under 12 years of age | take 1 softgel daily |
children under 2 years of age | ask a doctor |
Other Information
- Each softgel contains: sodium 7 mg VERY LOW SODIUM
- Store at room temperature between 15° to 30°C (59° to 86°F)
- FOR YOUR PROTECTION: Do not use if blister is torn or broken.
Inactive Ingredients
FD&C Red #40, FD&C Yellow #6, Gelatin USP, Glycerin USP, Polyethylene Glycol 400 NF, Purified Water USP, Sorbital USP
The drug product contained in this package is from NDC # 61301-8001, SWISSCAPS Romania srl.
Distributed by:
American Health Packaging
2550 John Glenn Avenue, Suite A
Columbus, OH 43217
712901
0412901/0216PS
Principal Display Panel – Carton – 100 Mg
NDC 60687-129-01
DOCUSATE SODIUM, USP
Stool Softener Laxative
100 mg
100 Softgels (10 x 10)
The drug product contained in this package is from NDC # 61301-8001,
SWISSCAPS Romania srl.
Distributed by:
American Health Packaging
2550 John Glenn Avenue, Suite A
Columbus, OH 43217
712901
0412901/0216PS
Principal Display Panel - Blister – 100 Mg
100 mg Docusate Sodium Softgel Blister (Card Print Docusate Sodium 100mg 10x10 712901)
DOCUSATE SODIUM, USP
Stool Softener Laxative
Softgel
100 mg
* Please review the disclaimer below.
