Label: STOOL SOFTENER AND LAXATIVE- docusate sodium and sennosides tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 68210-4180-5 - Packager: Spirit Pharmaceuticals LLC
- 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 December 5, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient (in each tablet)
- Purpose
- Uses
- Warnings
- Do not use
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
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Directions
take preferably at bedtime or as directed by a doctor
Age Starting Dosage Maximum Dosage adults & children 12 years of age & over 2 tablets once a day 4 tablets twice a day children 6 to under 12 years of age 1 tablet once a day 2 tablets twice a day children 2 to under 6 years ½ tablet once a day 1 tablet twice a day children under 2 years ask a doctor ask a doctor - Other information
- Inactive ingredients
- Questions or comments?
- Distributed by:
- Pouch
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INGREDIENTS AND APPEARANCE
STOOL SOFTENER AND LAXATIVE
docusate sodium and sennosides tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-4180 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) MALTODEXTRIN (UNII: 7CVR7L4A2D) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color red Score no score Shape ROUND Size 10mm Flavor Imprint Code S44 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68210-4180-5 50 in 1 POUCH; Type 0: Not a Combination Product 11/22/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 11/22/2021 Labeler - Spirit Pharmaceuticals LLC (179621011)