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Stool softener - Medication Information

Product NDC Code 51013-819
Drug Name

Stool softener

Type Brand
Active Ingredients
Docusate sodium 100 mg/1
Route ORAL
Dosage Form CAPSULE, LIQUID FILLED
RxCUI drug identifier 1115005
Application Number M007
Labeler Name PuraCap Pharmaceutical LLC
Packages
Package NDC Code Description
51013-819-01 100 capsule, liquid filled in 1 bottle (51013-819-01)
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Overdosage of Stool Softener

Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.
Overdose warning In case of overdose, get medical help or contact a Posion Control Center right away.

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient (in each softgel) Docusate Sodium 100 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 take with a glass of water -see Overdose warning adults and children 12 years of age and over 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses children 2 to under 12 years of age 1 softgel daily children under 2 years of age ask a doctor
adults and children 12 yearsof age and over1 to 3 softgels daily. This dose may be taken as a single daily doseor in divided doses
children 2 to under 12 years of age1 softgel daily
children under 2 years of ageask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients citric acid, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol sorbitan solution, purified water and white edible 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.
Use for relief of occasional constipation and irregularity. This product generally produces bowel movement in 12 to 72 hours.

Purpose

Information about the drug product’s indications for use.
Purpose Stool softener laxative

Spl product data elements

Usually a list of ingredients in a drug product.
Stool Softener Docusate Sodium 100mg GELATIN, UNSPECIFIED DOCUSATE SODIUM DOCUSATE PROPYLENE GLYCOL SORBITOL FD&C RED NO. 40 WATER ANHYDROUS CITRIC ACID POLYETHYLENE GLYCOL, UNSPECIFIED FD&C YELLOW NO. 6 GLYCERIN clear red PC1

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.
PuraVation Stool Softener Docusate Sodium - 100 mg EACH 100 SOFTGELS NDC 51013-819-01 PC09-00 DSS 100mg-100ct.jpg

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

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 or 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 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.

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 toll free: 1-855-215-8180

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 this product. 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 feeding
If pregnant or breast-feeding, ask a health professional before use.

Storage and handling

Information about safe storage and handling of the drug product.
Other information each softgel contains: sodium 5mg store at room temperature 15°-30° C (59°-86° F). Protect from excessive humidity contains FD&C Yellow No. 6

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 or 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 this product. 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 professional before use. Keep out of reach of children. Overdose warning In case of overdose, get medical help or contact a Posion Control Center 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