Label: SENNA AND DOCUSATE SODIUM tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 11534-090-01, 11534-090-60 - Packager: Sunrise Pharmaceutical Inc
- Category: HUMAN OTC DRUG LABEL
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 August 7, 2013
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- Official Label (Printer Friendly)
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS AND USAGE
- WARNINGS
- OTC - ASK A DOCTOR BEFORE USE IF YOU HAVE
- OTC - STOP USE AND ASK A DOCTOR IF
- OTC – IF PREGNANT OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
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DOSAGE AND ADMINISTRATION
- Take preferably at bedtime or as directed by a doctor
age starting dosage maximum dosage adults and children 12 years of age or older 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 ½ 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 INGREDIENT
Colloidal silicon dioxide, dicalcium phosphate, D&C yellow No 10 Aluminum Lake, ethanol, FD&C yellow No 6 Aluminum Lake, hydroxypropyl methyl cellulose, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, pregelatinized starch, silicon dioxide, sodium benzoate, stearic acid, talc, titanium dioxide
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SENNA AND DOCUSATE SODIUM
senna and docusate sodium tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11534-090 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 DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MINERAL OIL (UNII: T5L8T28FGP) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) STARCH, CORN (UNII: O8232NY3SJ) SODIUM BENZOATE (UNII: OJ245FE5EU) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TALC (UNII: 7SEV7J4R1U) ALCOHOL (UNII: 3K9958V90M) Product Characteristics Color ORANGE Score no score Shape ROUND Size 10mm Flavor Imprint Code S90 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11534-090-60 60 in 1 BOTTLE 2 NDC:11534-090-01 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 07/26/2007 Labeler - Sunrise Pharmaceutical Inc (168522378) Registrant - Sunrise Pharmaceutical Inc (168522378)