Label: SENEXON-S- docusate sodium -sennosides tablet, coated
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Contains inactivated NDC Code(s)
NDC Code(s): 33261-749-00 - Packager: Aidarex Pharmaceuticals LLC
- This is a repackaged label.
- Source NDC Code(s): 0536-4086
- 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 30, 2013
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- PURPOSE
- QUESTIONS
- STOP USE
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INACTIVE INGREDIENT
Inactive ingredients
carnauba wax, colloidal silicon dioxide, croscarmellose sodium
D-C yellow #10 aluminum lake, dibasic calcium phosphate
dihydrate, FD-C yellow #6 aluminum lake, hypromellose,
magnesium stearate, microcrystalline cellulose, polyethylene
glycol, sodium benzoate, stearic acide, Titanium dioxide
- WHEN USING
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DOSAGE & ADMINISTRATION
Dosage and Administration
Adults and children 12 years and over - 2 tablets once a day - maximum dosage - 4 tablets twice a day
children 6 to under 12 years - 1 tablet once a day maximum dosage - 2 tablets twice a day
children 2 to under 6 years - 1/2 tablet once a day - maximum dosage- 1 tablet twice a day
children uner 2 years - ask a doctor
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SENEXON-S
docusate sodium -sennosides tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:33261-749(NDC:0536-4086) 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 CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) SODIUM BENZOATE (UNII: OJ245FE5EU) STEARIC ACID (UNII: 4ELV7Z65AP) 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:33261-749-00 100 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 03/16/2011 Labeler - Aidarex Pharmaceuticals LLC (801503249)