Active Ingredient (In Each 5 Ml)
Docusate Sodium 50 mg
Kroger Stool Softener Liquid
FDA Label NDC 41226-714
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kroger Company for the product Kroger Stool Softener (NDC 41226-714). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each 5 ml), purpose, uses, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Stool Softener
Uses
▪ relieves occasional constipation (irregularity)▪ generally produces bowel movement in 12-72 hours
Warnings
Do not use
▪ laxative products for longer than 1 week unless directed by a doctor▪ stomach pain▪ nausea▪ vomiting▪ noticed a sudden change in bowel habits that continues over a period of 2 weeks
Ask a doctor before use if you have
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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.
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 |
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
Inactive Ingredients
Benzyl alcohol, citric acid, flavor, polyethylene glycol, povidone, propylene glycol, purified water, sodium citrate, sorbitol, sucralose, xanthan gum.
Questions Or Comments?
1-866-467-2748
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. |
* Please review the disclaimer below.
