Label: KROGER STOOL SOFTENER FRUIT PUNCH- docusate sodium liquid
- NDC Code(s): 41226-714-08
- Packager: KROGER COMPANY
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 12, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient (in each 5 mL)
- Purpose
- Uses
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Warnings
Do not use
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- laxative products for longer than 1 week unless directed by a doctor
Ask a doctor before use if you have
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- stomach pain
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- nausea
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- vomiting
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- 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.
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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Directions
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- follow dosing directions below or take as directed by doctor
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- must be given in a 6 to 8 oz glass of milk or fruit juice to prevent throat irritation
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- may be taken as a single daily dose or in divided doses
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- take maximum dose daily until first bowel movement, dosage should then be reduced according to individual response.
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- do not exceed recommended dose
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- 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
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
NDC 41226-714-08
Compare to the active ingredient in Colace® Clear*
Stool Softener Laxative
Docusate Sodium/ Stool SoftenerHelps 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.
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INGREDIENTS AND APPEARANCE
KROGER STOOL SOFTENER FRUIT PUNCH
docusate sodium liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41226-714 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 50 mg in 5 mL Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color Score Shape Size Flavor FRUIT PUNCH Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41226-714-08 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/27/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 03/27/2023 Labeler - KROGER COMPANY (006999528)