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Docusate sodium - Medication Information

Product NDC Code 0363-8991
Drug Name

Docusate sodium

Type Generic
Active Ingredients
Docusate sodium 100 mg/1
Route ORAL
Dosage Form CAPSULE, LIQUID FILLED
RxCUI drug identifier 1115005
Application Number M007
Labeler Name WALGREEN COMPANY
Packages
Package NDC Code Description
0363-8991-25 1 bottle, plastic in 1 package (0363-8991-25) / 25 capsule, liquid filled in 1 bottle, plastic
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient (in each liquid-filled capsule) 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 take by mouth. Doses may be taken as a single daily dose or in divided doses. Adults and children 12 years and over take 1 to 3 capsules daily. Children 2 to under 12 years of age 1 capsule daily. Children under 2 years of age Ask a doctor
Adults and children 12 years and overtake 1 to 3 capsules daily.
Children 2 to under 12 years of age1 capsule daily.
Children under 2 years of ageAsk a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients FD&C Red#40, FD&C Yellow#6, gelatin,glycerin, polyethylene glycol 400, propylene glycol, povidone, purified water, sorbitol solution, titanium dioxide.

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 of occasional constipation (irregularity) this product generally produces a bowel movement within 12 to 72 hours

Purpose

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

Spl product data elements

Usually a list of ingredients in a drug product.
DOCUSATE SODIUM DOCUSATE SODIUM POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL WATER GELATIN GLYCERIN SORBITOL FD&C RED NO. 40 FD&C YELLOW NO. 6 TITANIUM DIOXIDE DOCUSATE SODIUM DOCUSATE POVIDONE K30 125

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 Dulcolax ® Stool Softener active ingredient * GENTLE STOOL SOFTENER DOCUSATE SODIUM 100 mg / STOOL SOFTENER LAXATIVE 25 LIQUID GELS GSS

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 vomittiong 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 . In case of overdose, get medical help or contact a Poison Control Center right away.1(800)222-1222

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other information Store at room temperature 20-25°C (68-77°F) protect from excessive humidity do not use this product of the safety seal under the cap is torn or missing

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? 1-888-333-9792

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 you have rectal bleeding ot no bowel movement after using this product. These could be signs of a serious condition. yo need to use 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

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

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