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Product NDC Code | 54257-902 | ||||||
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Drug Name | Stool softener docusate sodium |
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Type | Brand | ||||||
Active Ingredients |
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Route | ORAL | ||||||
Dosage Form | CAPSULE, GELATIN COATED | ||||||
RxCUI drug identifier | 1115005 | ||||||
Application Number | M007 | ||||||
Labeler Name | Magno-Humphries, Inc. | ||||||
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 100mg
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 only by mouth. This dose may be taken as a single daily dose or in divided doses. take 1-3 softgels daily or as directed by a doctor adults and children over 12 years of age: take 1 softgel daily or as directed by a doctor children 2 to under 12 years of age: ask a doctor children under 2 years of age:
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, 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 relieves occasional constipation (irregularity) generally produces a bowel movement in 12-72 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.Stool Softener Docusate Sodium DOCUSATE SODIUM GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL 400 WATER SORBITOL 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.Package Labeling: Label Drug Facts
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.MHL NDC 54257-902-06 Stool Softener Docusate Sodium 100mg Compare to the active ingredient in Colace * ® Effective, Gentle Stimulant Free For Comfortable Relief 1000 SOFTGELS
Other information sodium 7mg each softgel contains: store between 15° to 30°C (59° to 86°F) Protect from moisture
*This product is not manufactured or distributed by the owner of the registered trademark Colace®. Distributed by: Magno-Humphries, Inc. OR 97223 U.S.A. Visit our website: www.magno-humphries.com *This product is not manufactured or distributed by the owner of the registered trademark Colace®. Distributed by: , OR 97223 U.S.A. Magno-Humphries, Inc. Visit our website: www.magno-humphries.com
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 PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED
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 accidental overdose, get medical help or contact a Poison Control Center ( ) right away. 1-800-222-1222
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? call toll-free 1-800-935-6737
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 Ask a doctor before use if you have Stop use and ask a doctor if ask a health professional before use. If pregnant or breast-feeding, if you are presently taking mineral oil, unless told by a doctor stomach pain nausea vomiting noticed a sudden change in bowel movements that continues over a period of 2 weeks you have rectal bleeding or you fail to have a bowel movement after use of a laxative. These could be signs of a serious condition. you need to use a stool softener for mroe than 1 week. Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center ( ) right away. 1-800-222-1222
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