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| Product NDC Code | 41226-714 | ||||
|---|---|---|---|---|---|
| Drug Name | Kroger stool softener fruit punch |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 1248119 | ||||
| Application Number | part334 | ||||
| Labeler Name | KROGER COMPANY | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each 5 mL) 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 • follow dosing directions below or take as directed by doctor • must be given in a 6 to 8 oz glass of milk or fruit juice to prevent throat irritation • may be taken as a single daily dose or in divided doses • take maximum dose daily until first bowel movement, dosage should then be reduced according to individual response. • do not exceed recommended dose • shake well before using Age Dose Adults and children 12 years and over 5 mL-30 mL Children 2 to under 12 years 5 mL-15 mL
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Benzyl alcohol, citric acid, flavor, polyethylene glycol, povidone, propylene glycol, purified water, sodium citrate, sorbitol, sucralose, xanthan gum.
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 12-72 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.Kroger Stool Softener Fruit Punch Docusate sodium DOCUSATE SODIUM DOCUSATE BENZYL ALCOHOL ANHYDROUS CITRIC ACID POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED PROPYLENE GLYCOL WATER SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCRALOSE XANTHAN GUM
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.Principal Display Panel NDC 41226-714-08 Compare to the active ingredient in Colace® Clear* Stool Softener Laxative Docusate Sodium/ Stool Softener Helps gently relieves Constipation Overnight Fruit Punch Flavor Naturally and Artificially Flavor 8 FL OZ (237 mL) Package Contains One Bottle Distributed by: *This product is not manufactured or distributed by Avrio Health L.P., owner of the registered trademark Colace ® Clear. IMPORTANT: Keep this carton for future reference on full labeling. Kroger Stool Softener Docusate Sodium Fruit Punch
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 at 1-800-222-1222.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information • each 5 mL contains: sodium 6 mg • low sodium • store at room temperature • protect from excessive heat • keep tightly closed • protect from light SAFETY SEALED: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING
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? 1-866-467-2748
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast feeding , ask a health 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 • laxative products for longer than 1 week 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 continues over a period of 2 weeks Stop use and ask a doctor if rectal bleeding of fail to have a bowel movement after use of laxative. These may indicate a serious condition.
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