Label: DOCUSATE SODIUM AND SENNA tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 61919-518-30, 61919-518-60, 61919-518-71 - Packager: DIRECT RX
- This is a repackaged label.
- Source NDC Code(s): 0536-0355
- 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 November 9, 2015
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- OTC - ACTIVE INGREDIENT SECTION
- OTC - PURPOSE SECTION
- OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- INDICATIONS & USAGE SECTION
- WARNINGS SECTION
- OTC - DO NOT USE SECTION
- OTC - ASK DOCTOR SECTION
- OTC - ASK DOCTOR/PHARMACIST SECTION
- OTC - STOP USE SECTION
- OTC - PREGNANCY OR BREAST FEEDING SECTION
- DOSAGE & ADMINISTRATION SECTION
- STORAGE AND HANDLING SECTION
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INACTIVE INGREDIENT SECTION
Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD-C blue #2 aluminum lake, FD-C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG), sodium benzoate, stearic acid, titanium dioxide
- OTC - QUESTIONS SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DOCUSATE SODIUM AND SENNA
docusate sodium and senna tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61919-518(NDC:0536-0355) 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) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FD&C RED NO. 40 (UNII: WZB9127XOA) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SODIUM BENZOATE (UNII: OJ245FE5EU) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color purple Score no score Shape ROUND Size 10mm Flavor Imprint Code TCL;131 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61919-518-60 60 in 1 BOTTLE 1 NDC:61919-518-30 30 in 1 BOTTLE 1 NDC:61919-518-71 100 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 01/01/2014 Labeler - DIRECT RX (079254320) Establishment Name Address ID/FEI Business Operations DIRECT RX 079254320 relabel(61919-518) , repack(61919-518)
