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Docusate sodium - Medication Information

Product NDC Code 72789-166
Drug Name

Docusate sodium

Type Generic
Active Ingredients
Docusate sodium 250 mg/1
Route ORAL
Dosage Form CAPSULE, LIQUID FILLED
RxCUI drug identifier 1245468
Application Number M007
Labeler Name PD-Rx Pharmaceuticals, Inc.
Packages
Package NDC Code Description
72789-166-60 60 capsule, liquid filled in 1 bottle, plastic (72789-166-60)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient (in each softgel) Docusate Sodium 250 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 Adults and Children over 12 years of age Take orally 1 softgel preferably at bedtime for 2-3 days or until bowel movements are normal, or as directed by a doctor. Children under 12 years of age Do not use this product for children under 12 years of age, unless directed by a doctor.
Adults and Children over 12 years of ageTake orally 1 softgel preferably at bedtime for 2-3 days or until bowel movements are normal, or as directed by a doctor.
Children under 12 years of ageDo not use this product for children under 12 years of age, unless directed by 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, Ink (Edible), Polyethylene Glycol, Propylene Glycol, Purified Water, 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 For the relief of occasional constipation. Helps to prevent dry, hard stools. This product generally produces a bowel movement within 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.
Docusate Sodium Docusate Sodium SORBITOL DOCUSATE SODIUM DOCUSATE FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL 1000 PROPYLENE GLYCOL WATER NV12

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.
Package/Label Principal Display Panel Docusate Sodium, USP Stool Softener 250 mg Each 72789166 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.
Other Information Each softgel contains 13 mg of Sodium. Store at room temperature between 15°C to 25°C (59°F to 77°F). Do not use if seal under cap is broken or missing.

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 notice a sudden change in bowel habits that persists over a period of two weeks.

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 (800) 222-1222.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions Quwstions of Comments Call 1 (800) 682-9862

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 you fail to have a bowel movement after use.

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast-feeding, ask a healthcare professional before use.

How supplied

Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.
HOW SUPPLIED For identification purposes, each softgel will have an imprint that reads NV12. NDC 72789-166-60 Bottles of 60 softgels.

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 currently taking mineral oil, unless directed by a doctor. When abdominal pain, nausea, or vomiting are present. For longer than one week unless directed by a doctor. Ask a doctor before use if you notice a sudden change in bowel habits that persists over a period of two weeks. Stop use and ask a doctor if you have rectal bleeding or you fail to have a bowel movement after use. If pregnant or breast-feeding, ask a healthcare professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (800) 222-1222.

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