Label: DOCUSATE SENNOSIDES tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 61919-771-60 - Packager: DIRECTRX
- This is a repackaged label.
- Source NDC Code(s): 49483-081
- 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 3, 2019
If you are a consumer or patient please visit this version.
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
INACTIVE INGREDIENTS: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, d-c yellow#10 aluminum lake fd&c yelow#6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, titanium dioxide - PURPOSE
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DOSAGE & ADMINISTRATION
Directions:
Take preferably at bedtime or as directed by a doctor. If you do not have a comfortable bowel movement by the second day, increase dose by one tablet (not to exceed maximum dosage) or decrease dose until you are comfortable.
Adults and children 12 years and over - starting dosage: 2 tablets once a day maximum dosage: 4 tablets twice a day
Children 6 to under 12 years - starting dosage: 1 tablet once a day maximum dosage: 2 tablets twice a day
Children to2 to under 6 years - starting dosage: 1/2 tablet once a day maximum dosage: 1 tablet twice a day
Children under 2 years - Ask a doctor
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DOCUSATE SENNOSIDES
docusate sennosides tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61919-771(NDC:49483-081) 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 A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN) SENNOSIDES A AND B 8.6 mg Inactive Ingredients Ingredient Name Strength STEARIC ACID (UNII: 4ELV7Z65AP) SODIUM BENZOATE (UNII: OJ245FE5EU) CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSES (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color orange Score no score Shape ROUND Size 9mm Flavor Imprint Code TCL081 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61919-771-60 60 in 1 BOTTLE; Type 0: Not a Combination Product 04/29/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 04/29/2019 Labeler - DIRECTRX (079254320) Registrant - DIRECTRX (079254320) Establishment Name Address ID/FEI Business Operations DIRECTRX 079254320 repack(61919-771)
