Active Ingredient (In Each Softgel)
Docusate Sodium 250 mg
Docusate Sodium Capsule, Liquid Filled
FDA Label NDC 54629-601
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by National Vitamin Company for the product Docusate Sodium (NDC 54629-601). 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, keep out of reach of children., uses, do not use:, ask a doctor before use, stop use and ask a doctor, if you are pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Stool Softener
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Uses
- For the relief of occasional constipation.
- Helps to prevent dry, hard stools.
- This product generally produces a bowel movement within 12 to 72 hours.
Do Not Use:
- If you are currently taking mineral oil, unless directed by a doctor.
- When abdominal pain, nausea, or vomiting are present.
- 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 two weeks.
Stop Use And Ask A Doctor
if you have rectal bleeding or you fail to have a bowel movement after use.
If You Are Pregnant Or Breast-Feeding,
ask a healthcare professional before use.
Directions
| Adults and Children over 12 years of age | Take orally 1 softgel preferably at bedtime for 2-3 days or until bowel movements are normal, or as directed by a doctor. |
| Children under 12 years of age | Do not use this product for children under 12 years of age, unless directed by a doctor. |
Other Information
- Each softgel contains 13 mg of Sodium.
- Keep lid tightly closed.
- Store at room temperature between 15°C to 30°C (59°F to 86°F).
- Do not use if printed seal under cap is broken or missing.
- For identification purposes, each softgel will have an imprint that reads NV12.
Inactive Ingredients
FD&C Red #40, FD&C Yellow #6, Gelatin, Glycerin, Ink (Edible), Polyethylene Glycol, Propylene Glycol, Purified Water, Sorbitol
Questions
Call 1 (800) 682-9862
Package/Label Principal Display Panel
NDC 54629-601-01
Life-Line®
Docusate Sodium, USP
Stool Softener
250 mg Each
100 Softgels
Manufactured and Distributed by
National Vitamin Company
Casa Grande, AZ 85122
Bottle Label (0c66642c 82cb 42cd 82bb 5f95852cc5d1 01)
* Please review the disclaimer below.
