FDA Label for Colace Extra Strength Stool Softner
View Indications, Usage & Precautions
Colace Extra Strength Stool Softner Product Label
The following document was submitted to the FDA by the labeler of this product Atlantis Consumer Healthcare Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Softgel)
Docusate Sodium 250 mg
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
Principal Display Panel
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
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