Label: STOOL SOFTENER PLUS LAXATIVE- docusate sodium, sennosides tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 63868-137-60 - Packager: QUALITY CHOICE (Chain Drug Marketing Association)
- Category: HUMAN OTC DRUG LABEL
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 November 8, 2022
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- Official Label (Printer Friendly)
- Active Ingredients (in each tablet)
- Purpose
- Uses
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Warnings
Do not use
- If you are now taking mineral oil, unless directed by a doctor
- 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.
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Directions
- Take preferably at bedtime or as directed by a doctor
age
starting dosage maximum dosage adults and children 12 years of age and older 2 tablets once a day 4 tablets twice a day children 6 to under 12 years 1 tablet once a day 2 tablets twice a day children 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day children under 2 years ask a doctor ask a doctor - Other information
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Inactive Ingredients
carnauba wax, croscarmellose sodium, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake*, FD&C red #40 aluminum lake*, FD&C yellow #6 aluminum lake, hypromellose*, magnesium stearate, maltodextrin*, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol*, silicon dioxide, sodium benzoate, stearic acid, talc* and titanium dioxide.
*contains one or more of these ingredients - Questions or comments?
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Principal Display Panel
†Compare to the active ingredients in Senokot-S®
Stool Softener plus laxative
Stool Softener • Laxative
Docusate Sodium, 50 mg/ Sennosides, 8.6 mg
Provides Gentle Relief of: Occasional ConstipationTablets
†This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Senokot-S®
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP ID BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Distributed by C.D.M.A., Inc©
43157 W. Nine Mile
Novi, MI 48376-0995
- Product Label
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INGREDIENTS AND APPEARANCE
STOOL SOFTENER PLUS LAXATIVE
docusate sodium, sennosides tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-137 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 SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES 8.6 mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM BENZOATE (UNII: OJ245FE5EU) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color orange Score no score Shape ROUND Size 10mm Flavor Imprint Code TCL081;0805;AV;S35 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-137-60 1 in 1 BOX 11/30/2015 1 60 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 11/30/2015 Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)