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Product NDC Code | 69842-523 | ||||
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Drug Name | Cvs health stool softener |
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Type | Brand | ||||
Active Ingredients |
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Route | ORAL | ||||
Dosage Form | CAPSULE | ||||
RxCUI drug identifier | 1247759 | ||||
Application Number | M007 | ||||
Labeler Name | CVS Pharmacy | ||||
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 50 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 only 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 6 softgels daily children 2 to under 12 years of age take 1 to 3 softgels daily children under 2 years ask a doctor
adults and children 12 years and over | take 1 to 6 softgels daily |
children 2 to under 12 years of age | take 1 to 3 softgels daily |
children under 2 years | ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients FD&C Red No. 40, gelatin, glycerin, polyethylene glycol-400, povidone, propylene glycol, 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 occasional constipation (irregularity) ■ generally produces bowel movement in 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.CVS Health Stool Softener Docusate sodium FD&C RED NO. 40 GELATIN GLYCERIN POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL POVIDONE K30 WATER SORBITOL TITANIUM DIOXIDE DOCUSATE SODIUM DOCUSATE S10
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.CVS Health Compare to the active ingredient in Colace Stool Softener DOCUSATE SODIUM, 50 mg • Stimulant free • Gentle & effective • Comfortable relief of constipation Actual Bottle Size on Side Pane 100 SOFTGELS RETAIN CARTON FOR COMPLETE PRODUCT INFORMATION TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace®. Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 © 2019 CVS/pharmacy CVS.com® 1-800-SHOP CVS Made in India V-33609 image description
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 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 have ■ stomach pain ■ nausea ■ vomiting ■ noticed a sudden change in bowel habits that lasts over 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.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 stool softener laxative for more than 1 week
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
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
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information ■ each softgel contains: sodium 3 mg VERY LOW SODIUM ■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F). Keep tightly closed.
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