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| Product NDC Code | 50268-268 | ||||
|---|---|---|---|---|---|
| Drug Name | Docusate sodium |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | CAPSULE, LIQUID FILLED | ||||
| RxCUI drug identifier | 1245468 | ||||
| Application Number | M007 | ||||
| Labeler Name | AvPAK | ||||
| Packages |
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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 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. |
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 FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GLYCERIN POLYETHYLENE GLYCOL 1000 PROPYLENE GLYCOL WATER SORBITOL DOCUSATE SODIUM DOCUSATE 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 NDC 50268-268-15 AvKARE Docusate Sodium, USP Stool Softener 250 mg Each 100 Softgels USA AV Rev. 05/16 (P) Manufactured for: AvKARE, Inc. Pulaski, TN 38478 1 2 3
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 30°C (59°F to 86°F). Do not use if printed seal under cap is broken or missing. For identification purposes, each softgel will have an imprint that reads NV12.
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.
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 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.
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions Call 1-855-361-3993
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 feedingIf you are pregnant or breast-feeding, ask a healthcare 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 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.
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