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Docusate sodium - Medication Information

Product NDC Code 73147-8273
Drug Name

Docusate sodium

Type Generic
Active Ingredients
Docusate sodium 100 mg/1
Route ORAL
Dosage Form CAPSULE
RxCUI drug identifier 1115005
Application Number M007
Labeler Name Cellchem Pharmaceutical Inc
Packages
Package NDC Code Description
73147-8273-1 100 capsule in 1 bottle (73147-8273-1)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient (in each capsule) Purpose Docusate sodium 100 mg................................................Laxative, stool softener

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 Adults and children 12 years and over: Take 1 - 2 capsules daily or as directed by physician Do not take more than 4 capsules per day. Drink lots of fluids (one full glass or more)

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Polyethylene glycol 400, propylene glycol, gelatin, glycerin, sodium methyl paraben, sodium propyl paraben, sorbitol sorbitan solution, purified water, FD&C Red No. 40, FD&C Yellow No. 6.

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 Relief of occasional constipation softens the stools

Purpose

Information about the drug product’s indications for use.
Stool Softener

Spl product data elements

Usually a list of ingredients in a drug product.
DOCUSATE SODIUM DOCUSATE SODIUM DOCUSATE SODIUM DOCUSATE PROPYLENE GLYCOL GELATIN GLYCERIN METHYLPARABEN SODIUM PROPYLPARABEN SODIUM SORBITOL SOLUTION FD&C RED NO. 40 FD&C YELLOW NO. 6 POLYETHYLENE GLYCOL 400 WATER Dark Red

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.
label

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.
Manufactured for : CellChem Pharmaceuticals Inc. Ottawa, ON, Canada K2E 7V7

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 have abdominal pain nausea fever vomiting with other medicines or if you are presently taking mineral oil if you are on a low salt diet longer than 7 days

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, call a poison control centre or get medical help right away, even if you do not notice any signs or symptoms.

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 rectal bleeding occurs symptoms persist, last for more than 7 days

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product frequent or prolonged use may result in dependence on laxatives it may take up to 3 days for you to have a bowel movement

Storage and handling

Information about safe storage and handling of the drug product.
Other information Questions ? 1(844) 481-8884

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 have abdominal pain nausea fever vomiting with other medicines or if you are presently taking mineral oil if you are on a low salt diet longer than 7 days When using this product frequent or prolonged use may result in dependence on laxatives it may take up to 3 days for you to have a bowel movement Stop use and ask a doctor if rectal bleeding occurs symptoms persist, last for more than 7 days

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