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SENNOSIDES,DOCUSATE SODIUM- s ennos ides ,docus ate s odium tablet, film coated Rugby Laboratories 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.
0490C-Rugby Drug Facts Active ingredients (in each tablet) Sennosides 8.6 mg Docusate sodium 50 mg Purposes Laxative Stool softener Uses relieves occasional constipation (irregularity) generally produces bowel movement in 6-12 hours Do not us e ■ if you are now taking mineral oil, unless directed by a doctor ■ laxative products for longer than 1 week unless directed by a doctor As k a doctor before us e if you have ■ stomach pain ■ nausea ■ vomiting ■ noticed a sudden change in bowel habits that continues over a period of 2 weeks Stop us e and as k 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. If pregnant or breas t-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Directions take preferably at bedtime or as directed by a doctor age s tarting dos age maximum dos age adults and children 12 years and over 2 tablets once a day 4 tablets twice a day children 6 to under 12 years 1 tablets once a day 2 tablets twice a day
children 2 to under 6 years 1/2 tablet once a day 1 tablets twice a day children under 2 years ask a doctor ask a doctor Other information ■ each tablet contains : calcium 11 mg ■ each tablet contains : sodium 4 mg ■ store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) croscarmellose sodium, dicalcium phosphate, FD&C yellow #5 lake†, FD&C yellow #6 lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, sodium benzoate, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide and triacetin †contains FD&C yellow #5 lake (tartrazine) as a color additive. Questions or comments? 1-800-645- This is a bulk package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP. TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Rugby Laboratories is not affiliated with the owner of the registered trademark Senokot-S.® Distributed by: Rugby Laboratories 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 www.rugbylaboratories.com THIS PACKAGE IS FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN Rugby NDC 0536-1169- Senexon-S NATURAL VEGETABLE INGREDIENT STIMULANT LAXATIVE PLUS STOOL SOFTENER Docusate Sodium 50 mg Sennosides 8.6 mg 1000 TABLETS COMPARE TO THE ACTIVE INGREDIENTS IN SENOKOT-S® ®
SENNOSIDES,DOCUSATE SODIUM
sennosides,docusate sodium tablet, film coated Product Information Prod uct T yp e HUMAN O TC DRUG^ Ite m Cod e (S ource ) NDC:0 536 -116 9 Route of Ad minis tration O RAL Active Ing redient/Active Moiety Ing redient Name Basis o f Streng th Streng th DO CUSATE SO DIUM (UNII: F0 5Q 2T2JA0 ) (DO CUSATE - UNII:M7P2719 5AG) DO CUSATE SO DIUM 50 mg SENNO SIDES (UNII: 3FYP5M0 IJX) (SENNO SIDES - UNII:3FYP5M0 IJX) SENNO SIDES 8 .6 mg Inactive Ing redients Ing redient Name Streng th FD&C YELLO W NO. 6 (UNII: H77VEI9 3A8 )
Rugby Laboratories LIGHT MINERAL O IL (UNII: N6 K578 7Q VP) TALC (UNII: 7SEV7J4R1U) CRO SCARMELLO SE SO DIUM (UNII: M28 O L1HH48 ) CALCIUM PHO SPHATE, DIBASIC, DIHYDRATE (UNII: O 7TSZ9 7GEP) HYPRO MELLO SES (UNII: 3NXW29 V3WO ) MICRO CRYSTALLINE CELLULO SE (UNII: O P1R32D6 1U) SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J) STARCH, CO RN (UNII: O 8 232NY3SJ) STEARIC ACID (UNII: 4ELV7Z6 5AP) FD&C YELLO W NO. 5 (UNII: I753WB2F1M) TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) TRIACETIN (UNII: XHX3C3X6 73) MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 ) MALTO DEXTRIN (UNII: 7CVR7L4A2D) SO DIUM BENZO ATE (UNII: O J245FE5EU) PO LYETHYLENE GLYCO L 4 0 0 (UNII: B6 9 78 9 4SGQ ) Product Characteristics Color ye llo w^ S core no sc o re S hap e RO UND^ S iz e 10 mm Flavor Imp rint Cod e CPC;49 0 **Contains Packag ing
Item Co de Packag e Descriptio n Marketing Start Date Marketing End Date
1** NDC:0 536 -116 9 -10 10 0 0 in 1 BO TTLE; Type 0 : No t a Co mbina tio n Pro duc t 12/17/20 18 2 NDC:0 536 -116 9 -0 1 10 0 in 1 BO TTLE; Type 0 : No t a Co mbina tio n Pro duc t 12/13/20 18
Marketing Information
Marke ting Cate gory Ap p lication Numb e r or Monograp h Citation Marke ting S tart Date Marke ting End Date O TC mo no gra ph no t fina l pa rt334 12/13/20 18
Labeler - Rugby Laboratories (079246066)
Revised: 5/
