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| Product NDC Code | 67618-101 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Colace |
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| Type | Brand | ||||||||||||
| Active Ingredients |
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| Route | ORAL | ||||||||||||
| Dosage Form | CAPSULE | ||||||||||||
| RxCUI drug identifier | 1115005, 1247756 |
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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 capsule): Docusate sodium 100 mg
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.Drug Facts Colace 100 mg
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients D&C Red No. 33, FD&C Blue #1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, PEG 400, propylene glycol, sorbitol, titanium dioxide Avrio Health L.P. 304996-0A
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.Purpose Stool softener
Spl product data elements
Usually a list of ingredients in a drug product.Colace Docusate sodium Docusate sodium docusate D&C RED NO. 33 FD&C RED NO. 40 GELATIN GLYCERIN POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL SORBITOL FD&C BLUE NO. 1 FD&C YELLOW NO. 6 TITANIUM DIOXIDE RPC;053
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.Colace 100mg 100 Capsules Carton 305995-0B
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over2 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.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. Keep out of reach of children. In caseof overdose, get medical help or contact a Poison Control Center rightaway. Directions: Take only by mouth. Dosesmay be taken as a single daily dose or in divided doses. adults and children 12 yearsand over take 1-3 capsules daily children 2 to under 12 yearsof age take 1 capsules daily children under 2 years ask a doctor
| adults and children 12 yearsand over | take 1-3 capsules daily |
| children 2 to under 12 yearsof age | take 1 capsules daily |
| children under 2 years | ask a doctor |
Storage and handling
Information about safe storage and handling of the drug product.Otherinformation each capsule contains: sodium 5 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