Label: SENNA-S- sennosides and docusate sodium tablet, film coated
- NDC Code(s): 61715-019-60
- Packager: Kinray Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active Ingredients
Sennosides from Senna Concentrate 8.6 mg
Sodium Dioctylsulfosuccinate 50 mgClose
Sennosides from Senna Concentrate 8.6 mg...........LaxativeClose
Sodium Dioctylsulfosuccinate 50 mg......................Stool Softener
- Relieves occasional constipation (irregularity)
- Generally produces a bowel movement in 6-12 hours.
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.
Stop use and ask a doctor if
- you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.
Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center right away.
- 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
- each tablet contains calcium 20 mg, sodium 6mg Low Sodium
- store at room temperature between 15-300C (59-860F)
- 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 dioxideClose
- Questions? Adverse drug event call: (866) 562-2756
- INGREDIENTS AND APPEARANCE
sennosides and docusate sodium tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61715-019 Route of Administration ORAL DEA Schedule 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)