Active Ingredient (In Each Softgel)
Docusate Sodium 250 mg
Colace Extra Strength Capsule, Liquid Filled
FDA Label NDC 67618-201
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Atlantis Consumer Healthcare Inc. for the product Colace Extra Strength (NDC 67618-201). 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
Uses
- relieves occasional constipation (irregularity)
• generally produces a bowel movement within 12 to 72 hours.
Warnings
Do not useif 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
- you have rectal bleeding or fail to have a bowel movement after use of a laxative.
These can be signs of a serious condition - you need to use a stool softner laxative for more than 1 week
Stop use and ask a doctor if
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
If swallowed, get medical help or contact a Poison Control Center immediately.
Directions
adults and children 12 years of age and older | take 1 softgel daily or as directed by a doctor. |
children under 12 years of age | ask a doctor |
Other Information
- each softgel contains:sodium 15mg
- store at 20-25°C (68-77°F).
- Keep carton for full product information
Inactive Ingredients
gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol titanium dioxide
Questions?
1-833-288-2684
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EXTRA STRENGTH
#1 DOCTOR RECOMMENDED
Stool Softner Brand
COLACE
Docusate Sodium, 250mg
EXTRA STRENGTH
Stool Softner
√Gentle & Effective
√Relieves Constipation
√Cramp & Stimulant-Free
√Dye & Preservative-Free √
60 Clear Soft Gels
Retain this carton for important information.
Dis. By: Atlantis Consumer Healthcare Inc.
Bridgewater, NJ 08807 USA
Questions? 1-833-288-2684
©2024 Atlantis Consumer Healthcare Inc.
Colace is a registered trademark of Atlantis Consumer Healthcare Inc.
A0824
Colace Extra Strength 250mg 60 Softgels (73a71a65 1693 4c79 Bd8f 6e0da1dea033 00)
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