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| Product NDC Code | 67618-110 | ||||||||
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| Drug Name | Colace |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | ORAL | ||||||||
| Dosage Form | TABLET, FILM COATED | ||||||||
| RxCUI drug identifier | 998740, 1872920 |
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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 Active ingredient Purpose Docusate sodium 50 mg Stool softener Sennosides 8.6 mg Stimulant laxative
| Docusate sodium 50 mg | Stool softener |
| Sennosides 8.6 mg | Stimulant laxative |
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 Take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses. adults and children 12 years and over take 2-4 tablets daily children 6 to under 12 years of age take 1-2 tablets daily children 2 to under 6 years of age take up to 1 tablet daily children under 2 ask a doctor
| adults and children 12 years and over | take 2-4 tablets daily |
| children 6 to under 12 years of age | take 1-2 tablets daily |
| children 2 to under 6 years of age | take up to 1 tablet daily |
| children under 2 | ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients croscarmellose sodium, dicalcium phosphate, FD&C Blue #1 Lake, FD&C Red #40 Lake, FD&C Yellow #6 Lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, sodium benzoate, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide, triacetin. Dist. by: Atlantis Consumer Healthcare inc. Bridgewater, NJ 08801 USA Questions? 1-833-286-2684 ©2023 Atlantis Consumer Healthcare inc. Colace is a registered trademark of Atlantis Consumer Healthcare Inc. A1023 R52504
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 6 to 12 hours
Spl product data elements
Usually a list of ingredients in a drug product.Colace Docusate sodium - sennosides DOCUSATE SODIUM DOCUSATE SENNOSIDES SENNOSIDES CROSCARMELLOSE SODIUM ANHYDROUS DIBASIC CALCIUM PHOSPHATE FD&C BLUE NO. 1 FD&C RED NO. 40 FD&C YELLOW NO. 6 HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MALTODEXTRIN MICROCRYSTALLINE CELLULOSE 102 MINERAL OIL POLYETHYLENE GLYCOL, UNSPECIFIED SODIUM BENZOATE SODIUM LAURYL SULFATE STARCH, CORN STEARIC ACID TALC TITANIUM DIOXIDE TRIACETIN burgundy P;054 60 count carton 30 count carton 10 count carton 10 count blister 30 count lable 60 count lable
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, 50 mg Sennosides 8.6 mg 2-IN-1 Stool Softener + Stimulant Laxative √ Gentle, Effective, & Dependable √ Constipation Relief in 6 `12 hours 10 Tablets Colace® 2-IN-1 Tablets Docusate Sodium Sennosides Dist. by: Atlantis Consumer Healthcare Inc. LOT XXXXXX EXP YYYY-MM #1 DOCTOR RECOMMENDED Stool Softener Brand Colace® Docusate Sodium, 50 mg Sennosides 8.6 mg 2-IN-1 Stool Softener + Stimulant Laxative √ Gentle, Effective, & Dependable √ Constipation Relief in 6 `12 hours 30 Tablets Retain this carton for Important information Dist. by: Atlantis Consumer Healthcare inc. Bridgewater, NJ 08801 USA Questions? 1-833-286-2684 ©2023 Atlantis Consumer Healthcare inc. Colace is a registered trademark of Atlantis Consumer Healthcare Inc. A1023 R52506 Colace® Docusate Sodium Sennosides 2-IN-1 Stool Softener + Stimulant Laxative 30 Tablets Do not use if imprinted seal under cap is missing or damaged. See carton for additional information Dist. by: Atlantis Consumer Healthcare inc. Bridgewater, NJ 08801 USA Questions? 1-833-286-2684 ©2023 Atlantis Consumer Healthcare inc. Colace is a registered trademark of Atlantis Consumer Healthcare Inc. A1023 R52507 #1 DOCTOR RECOMMENDED Stool Softener Brand Colace® Docusate Sodium, 50 mg Sennosides 8.6 mg 2-IN-1 Stool Softener + Stimulant Laxative √ Gentle, Effective, & Dependable √ Constipation Relief in 6 `12 hours Retain this carton for Important information For added savings, visit: colacecapsules.com Dist. by: Atlantis Consumer Healthcare inc. Bridgewater, NJ 08801 USA Questions? 1-833-286-2684 ©2023 Atlantis Consumer Healthcare inc. Colace is a registered trademark of Atlantis Consumer Healthcare Inc. A1023 R52508 60 Tablets A1023 R52507 Colace® Docusate Sodium Sennosides 2-IN-1 Stool Softener + Stimulant Laxative 60 Tablets Do not use if imprinted seal under cap is missing or damaged. See carton for additional information Dist. by: Atlantis Consumer Healthcare inc. Bridgewater, NJ 08801 USA Questions? 1-833-286-2684 ©2023 Atlantis Consumer Healthcare inc. Colace is a registered trademark of Atlantis Consumer Healthcare Inc. LOT: EXP: A1023 R52509
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 laxative products for longer than 1 week unless told to do so by a doctor 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 movement after use of a laxative. These could be signs of a serious condition.
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 tablet contains: calcium 7 mg, sodium 4 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