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| Product NDC Code | 67618-201 | ||||
|---|---|---|---|---|---|
| Drug Name | Colace extra strength stool softner |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | CAPSULE, LIQUID FILLED | ||||
| RxCUI drug identifier | 1245468, 2692740 |
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| Application Number | M007 | ||||
| Labeler Name | Atlantis Consumer Healthcare Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each softgel) Docusate Sodium 250 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol. Softgels are imprinted with edible, dye-free ink.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses relieves occasional constipation (irregularity) • generally produces a bowel movement within 12 to 72 hours.
Purpose
Information about the drug product’s indications for use.Purpose Stool softener
Spl product data elements
Usually a list of ingredients in a drug product.COLACE EXTRA STRENGTH STOOL SOFTNER Docusate Sodium GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED CROSPOVIDONE (120 .MU.M) PROPYLENE GLYCOL WATER SORBITOL DOCUSATE SODIUM DOCUSATE C250
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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 Colace Extra strength 250mg 60 softgels
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-833-288-2684
Storage and handling
Information about safe storage and handling of the drug product.Other information each softgel contains: sodium 15mg store at 20-25°C (68-77°F). Keep carton for full product information
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Do not use if 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 Stop use and ask a doctor if 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 If pregnant or breast-feeding , ask a health care professional before use. Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center immediately.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API