Label: SENOKOT-S- docuset sodium pill
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Contains inactivated NDC Code(s)
NDC Code(s): 42787-105-12 - Packager: Ajes 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 May 25, 2014
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions - take preferably at bedtime or as directed by a doctor
Age Starting dose Maximum Dose
Adults and children 12 years of age or older 2 tablets once a day - 4 tablets twice a day
children 6 to 12 years of age - 1 tablet once a day 2 tablets twice a day
children 2 to 6 years of age 1/2 tablet once a day 1 tablet twice a day
children under 2 years of age ask a doctor
- INACTIVE INGREDIENT
- ASK DOCTOR
- PREGNANCY
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SENOKOT-S
docuset sodium pillProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42787-105 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 340 mg SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES 8.6 mg in 340 mg Inactive Ingredients Ingredient Name Strength COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FD&C RED NO. 40 (UNII: WZB9127XOA) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TALC (UNII: 7SEV7J4R1U) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) Product Characteristics Color orange (orange color) Score no score Shape ROUND (Pill) Size 10mm Flavor Imprint Code C18 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42787-105-12 1 in 1 BOX 1 50000 mg in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 09/01/2012 Labeler - Ajes Pharmaceuticals,LLC (159945393) Establishment Name Address ID/FEI Business Operations Ajes Pharmaceuticals,LLC 159945393 manufacture(42787-105) , repack(42787-105) , relabel(42787-105)
