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| Product NDC Code | 80136-951 | ||||
|---|---|---|---|---|---|
| Drug Name | Stool softener |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | CAPSULE | ||||
| RxCUI drug identifier | 1115005 | ||||
| Application Number | M007 | ||||
| Labeler Name | NORTHEAST PHARMA (Heartland Pharma) | ||||
| 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 100 mg Purpose Stool softener 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 or in divided doses. adults and children 12 years and over take 1-3 softgels daily children 2 to under 12 years of age take 1 softgel daily children under 2 years ask a doctor
| adults and children 12 years and over | take 1-3 softgels daily |
| children 2 to under 12 years of age | take 1 softgel daily |
| children under 2 years | ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol
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 and irregularity generally produces a bowel movement in 12 to 72 hours.
Purpose
Information about the drug product’s indications for use.Purpose Stool softener laxative
Purpose Stool Softener Laxative
Spl product data elements
Usually a list of ingredients in a drug product.Stool Softener DOCUSATE SODIUM DOCUSATE SODIUM DOCUSATE FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SORBITOL SORBITAN P51
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 Compare to active ingredient in COLACE® REGULAR STRENGTH† STOOL SOFTENER Docusate Sodium 100 mg Stool Softener Laxative Gentle dependable Stimulant-Free Softgels TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. Distributed by NORTHEAST PHARMA South Burlington, VT 05403 www.heartlandpharma.com
Product Label HEARTLAND PHARMA Stool Softener Docusate Sodium 100 mg
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 a sudden change in bowel habits that lasts more than 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.Do not use if you are presently taking mineral oil, unless directed 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 (1-800-222-1222) right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments ? Call 1- 800-383-0648
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 no bowel movement after using laxative. These could be signs of a serious condition. you need to use a laxative for more than 1 week
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health care professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information each softgel contains: sodium 5 mg store at 25 o C (77 o ); excursions permitted between 15-30 o C (59-86 o F)
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 directed by a doctor Ask a doctor before use if you have stomach pain nausea vomiting a sudden change in bowel habits that lasts more than 2 weeks Stop use and ask a doctor if you have rectal bleeding or no bowel movement after using laxative. These could be signs of a serious condition. you need to use a laxative for more than 1 week If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
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