Label: SENNA-S- sennosides and docusate sodium tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 61715-019-60 - Packager: Kinray Inc.
- 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 March 26, 2013
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredients
- Purposes
- Uses
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Warnings
Do not use
- laxative products for longer than 1 week unless directed by a doctor
- if you are now taking mineral oil, unless directed by a doctor
Ask a doctor before use if you have
- stomach pain, nausea, vomiting, noticed a sudden change in bowel habits that continues over a period of 2 weeks.
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Directions
- take preferably at bedtime or as directed by a doctor
age starting dosage maximum dosage adults and children 12 years of age and over
2 tablets once a day
4 tablets twice a day
children 6 to under 12 years
1 tablet once a day
2 tablets twice a day
children 2 to under 6 years
1/2 tablet once a day
1 tablet twice a day
children under 2 years
ask a doctor
ask a doctor
- Other Information
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Inactive ingredients
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, tapoica starch, tartaric acid, titanium dioxide
- Questions? Adverse drug event call: (866) 562-2756
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SENNA-S
sennosides and docusate sodium tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61715-019 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES 8.6 mg DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 50 mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) SODIUM BENZOATE (UNII: OJ245FE5EU) STEARIC ACID (UNII: 4ELV7Z65AP) STARCH, TAPIOCA (UNII: 24SC3U704I) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color orange (orange) Score no score Shape ROUND (round shape) Size 10mm Flavor Imprint Code S90 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61715-019-60 1 in 1 CARTON 1 60 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 05/10/2011 Labeler - Kinray Inc. (012574513) Registrant - Pharbest Pharmaceuticals Inc. (557054835) Establishment Name Address ID/FEI Business Operations Pharbest Pharmaceutical Inc. 557054835 repack(61715-019) , relabel(61715-019)