Active Ingredient (In Each Softgel)
Docusate Calcium 240 mg
Docusate Calcium
FDA Label NDC 76413-307
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Central Texas Community Health Centers for the product Docusate Calcium (NDC 76413-307). 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, do not use, ask a doctor before use if, 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
for relief of occasional constipation. 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 1 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
- you fail to have a bowel movement after use
These could be signs of s serious condition.
If Pregnant Or Breast-Feeding,
ask a health care 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
- adults and children over 12 years of age: take 1 softgel daily for several days, or until bowel movements are normal, or as directed by a doctor
- children under 12 years of age: take as directed by a doctor
Other Information
- store between 15°-30°C (59°-86°F)
Inactive Ingredients
corn oil, D&C red #33, edible white ink, FD&C red #40, gelatin, glycerin, purified water and sorbitol special.
Questions Or Comments?
1-800-645-2158
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Compare to active ingredient in SURFAK®*
Safe, Effective, Non-Habit Forming
Stool Softener Laxative DC
Docusate Calcium USP, 240 mg
SOFTGEL CAPSULES
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*Rugby Laboratories is not affiliated with the owner of the trademark Surfak®.
Distributed by: Rugby Laboratories
31778 Enterprise Drive
Livonia, MI 48150
www.rugbylaboratories.com
Principal Display Panel - 240 Mg Capsule Bottle Label
CommUnityCare Federally Qualified Health Centers
DOCUSATE
CALCIUM
240 MG
CAPS
Date:
Name:
Dr.
TAKE 1 CAPSULE BY MOUTH DAILY AS DIRECTED.
123456
1/1/01
DOCUSATE CA.240MG CAPS#30NDC 76413-307-30
Batch: 123456
Lot: 123456
Exp: 1/1/01
MAJOR
Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.
Principal Display Panel (240 mg Capsule Bottle Label)
* Please review the disclaimer below.
