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| Product NDC Code | 67618-111 | ||||||||
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| Drug Name | Colace |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | ORAL | ||||||||
| Dosage Form | CAPSULE, LIQUID FILLED | ||||||||
| RxCUI drug identifier | 1247759, 1247761 |
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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.Drug Facts
Dosage forms and strengths
Information about all available dosage forms and strengths for the drug product to which the labeling applies. This field may contain descriptions of product appearance.Directions Take only by mouth. Doses may be taken as a single daily dose or in divided doses. adults and children 12 years and over take 1-6 soft gels daily children 2 to under 12 years of age take 1-3 soft gels daily children under 2 years ask a doctor
| adults and children 12 years and over | take 1-6 soft gels daily |
| children 2 to under 12 years of age | take 1-3 soft gels daily |
| children under 2 years | ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients gelatin, glycerin, PEG 400, propylene glycol, sorbitol Soft gels are imprinted with edible dye-free ink. Dist. by: Atlantis Consumer Healthcare Inc. Bridgewater, NJ 08807 Questions? 1-833-288-2684 ©2023 Atlantis Consumer Healthcare Inc. Colace is a registered trademark of Atlantis Consumer Healthcare Inc.
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 bowel movement in 12 to 72 hours
Purpose
Information about the drug product’s indications for use.Active ingredient Purpose (in each soft gel) Docusate sodium 50 mg........... Stool softener
| Docusate sodium 50 mg........... | Stool softener |
Spl product data elements
Usually a list of ingredients in a drug product.Colace Docusate sodium DOCUSATE SODIUM DOCUSATE GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL SORBITOL clear to light brown CLR;50 42 count carton 60 count carton
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.PACKAGE LABEL.PRINCIPAL DISPLAY PANEL #1 DOCTOR RECOMMENDED Stool Softener Brand Colace Docusate Sodium, 50mg CLEAR Stool Softener √ Gentle, Effective Relief √ Dye & Preservative-free √ Cramp & Stimulant-free 28 Clear Soft Gels Front Panel #1 DOCTOR RECOMMENDED Stool Softener Brand Colace ® Docusate Sodium, 50mg CLEAR Stool Softener √ Gentle, Effective Constipation Relief √ Stimulant-Free & Dye-Free 42 Clear Soft Gels Side Panel Colace ® Docusate Sodium, 50mg √ Dye & Preservative-Free √ Stimulant -Free √ No Artificial Sweeteners √ Non -GMO Retain this carton for Important information. For added savings, visit: colacecapsules.com Dist. by: Atlantis Consumer Healthcare Inc. Bridgewater, NJ 08807 USA Questions? 1-833-288-2684 ©2023 Atlantis Consumer Healthcare Inc. Colace is a registered trademark of Atlantis Consumer Healthcare Inc. Lot No.: Exp. Date: A0923 Front Panel #1 DOCTOR RECOMMENDED Stool Softener Brand Colace ® Docusate Sodium, 50mg CLEAR Stool Softener √ Gentle, Effective Constipation Relief √ Stimulant-Free & Dye-Free 60 Clear Soft Gels Side Panel Colace ® Docusate Sodium, 50mg √ Dye & Preservative-Free √ Stimulant -Free √ No Artificial Sweeteners √ Non -GMO Retain this carton for Important information. For added savings, visit: colacecapsules.com Dist. by: Atlantis Consumer Healthcare Inc. Bridgewater, NJ 08807 USA Questions? 1-833-288-2684 ©2023 Atlantis Consumer Healthcare Inc. Colace is a registered trademark of Atlantis Consumer Healthcare Inc. Lot No.: Exp. Date: A1123 304999-0B
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Warnings Do not use if you are presently taking mineral oil, unless told to do so by a doctor
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. In case of overdose, get medical help or contact a Poison Control Center right away.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movementafter use of a laxative. These could be signs of a serious condition. you need to use a stool softener laxative for more than1 week
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.Other information each soft gel contains: sodium 3 mg VERY LOW SODIUM store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F). Keep tightly closed.
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