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Product NDC Code | 80513-100 | ||||
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Drug Name | Docusate sodium, extra strength 250 mg |
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Type | Brand | ||||
Active Ingredients |
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Route | ORAL | ||||
Dosage Form | CAPSULE, GELATIN COATED | ||||
RxCUI drug identifier | 1245468 | ||||
Application Number | M007 | ||||
Labeler Name | Advanced Rx LLC | ||||
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 12 years of age and over: take 1 softgel daily or as directed by a doctor children under 12 years of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS edible ink, FD&C red #40, FD&C yellow #6, gelatin (bovine), glycerin, polyethylene glycol, purified water, sorbitol special.
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 prevention of dry, hard stools for relief of occasional constipation 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 laxative
Spl product data elements
Usually a list of ingredients in a drug product.DOCUSATE SODIUM, EXTRA STRENGTH 250 MG DOCUSATE SODIUM FD&C YELLOW NO. 6 FD&C RED NO. 40 GLYCERIN GELATIN TYPE B BOVINE (160 BLOOM) POLYETHYLENE GLYCOL, UNSPECIFIED WATER SORBITOL SOLUTION DOCUSATE SODIUM DOCUSATE SCU1
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.01b lbl-PDP_Docusate Sodium_250mg_100 01b lbl-DF_Docusate Sodium_250mg_100
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 (1-800-222-1222) 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 1-800-630-8895
Storage and handling
Information about safe storage and handling of the drug product.OTHER INFORMATION each softgel contains: sodium 20 mg store at 20°- 25°C (68°- 77°F); excursions permitted between 15°-30°C (59°-86°F)
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 directed by a doctor. Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. 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.
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