Label: STIMULANT LAXATIVE PLUS STOOL SOFTENER- docusate sodium 50 mg and sennosides 8.6 mg tablet, film coated
- NDC Code(s): 68788-7674-1, 68788-7674-6
- Packager: Preferred Pharmaceuticals, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0536-1248
- 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 September 25, 2023
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- Official Label (Printer Friendly)
- Active Ingredients (in each tablet)
- Purpose
- Uses
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Warnings
Do not use
- •
- laxative products for longer than 1 week unless told to do so by a doctor
- •
- if you are presently taking mineral oil, unless told to do so 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 2 weeks
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Directions
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- take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses
adults and children 12 years and over
take 2-4 tablets daily
children 6 to under 12 years of age
take 1-2 tablets daily
children 2 to under 6 years of age
take upto 1 tablet daily
children under 2
ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
STIMULANT LAXATIVE PLUS STOOL SOFTENER
docusate sodium 50 mg and sennosides 8.6 mg tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-7674(NDC:0536-1248) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES 8.6 mg DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 50 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) FD&C RED NO. 40 (UNII: WZB9127XOA) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) SODIUM BENZOATE (UNII: OJ245FE5EU) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color red Score no score Shape ROUND (ROUND TABLET) Size 10mm Flavor Imprint Code PH32 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68788-7674-6 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/28/2020 2 NDC:68788-7674-1 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/28/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 02/28/2020 Labeler - Preferred Pharmaceuticals, Inc. (791119022) Registrant - Preferred Pharmaceuticals, Inc. (791119022) Establishment Name Address ID/FEI Business Operations Preferred Pharmaceuticals, Inc. 791119022 REPACK(68788-7674)
