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Senna-S OTC Drug: Docusate Sodium and Sennosides Tablets, Lecture notes of Medical Sciences

Product information for senna-s, an over-the-counter (otc) drug containing docusate sodium and sennosides. The drug is used as a stool softener and stimulant laxative to relieve occasional constipation. Directions for use, warnings, and other important information for users. It also includes the drug facts, inactive ingredients, and the principal display panel.

What you will learn

  • What other information is included in the Senna-S product information document?
  • What are the directions for using Senna-S and what warnings should be considered?
  • What is the purpose of Senna-S and what are its active ingredients?

Typology: Lecture notes

2021/2022

Uploaded on 09/12/2022

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SENNA/DOCUSATE SODIUM - do cusate s o dium and sennos ides tablet, film coate d
Phys icians Total Care, Inc.
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.
----------
Senna-S
TAMPER-EVIDENT : Do not use this produc t if imprinted foil s eal over the mouth of the bottle is cut,
torn, broken or missing.
Drug Facts
Active ingredients
(in each tablet) Purposes
Docusate sodium 50 mg Stoo l softener
Sennosides 8.6 mg Stimulant laxative
Purposes
Docusate sodium 50 mg Stoo l softener
Sennosides 8.6 mg Stimulant laxative
Us es
relie ves occ asional constipation (irreg ularity)
ge nerally causes bo we l movement in 6 to 12 ho urs
Warnings
Do not us e
this pr oduct if you ar e pr es ently taking mineral oil, unless dire cted by a doctor
laxative pro ducts fo r longe r than 1 week unless dir ec ted by a doctor
As k a do ctor before us e if you have
stomach pain
nausea
vomiting
a sudde n change in bowe l habits that persis ts o ver 2 we eks
Stop use and ask a doctor if you
have rec tal ble eding
fail to have a bowel movement after us e of a laxative
these could be s ig ns of a se rious conditio n
If pregnant or breas t-feeding, ask a health professional befo re use.
Keep out of reac h of children. In case o f o verodse , get medical help or contact a Poiso n Control
Center rig ht away.
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SENNA/DOCUSATE SODIUM - docus ate s odium and s ennos ides tablet, film coated Phys icians Total Care, Inc. 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.


Senna-S TAMPER-EVIDENT: Do not use this product if imprinted foil seal over the mouth of the bottle is cut, torn, broken or missing. Drug Facts Active ingredients (in each tablet) Purposes Docusate sodium 50 mg Stool softener Sennosides 8.6 mg Stimulant laxative Purposes Docusate sodium 50 mg Stool softener Sennosides 8.6 mg Stimulant laxative Us es relieves occasional constipation (irregularity) generally causes bowel movement in 6 to 12 hours Warnings Do not us e this product if you are presently 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 a sudden change in bowel habits that persists over 2 weeks Stop us e and as k a doctor if you have rectal bleeding fail to have a bowel movement after use of a laxative these could be signs of a serious condition If pregnant or breas t-feeding, ask a health professional before use. Keep out of reach of children. In case of overodse, get medical help or contact a Poison Control Center right away.

Directions take preferably at bedtime or as directed by a doctor if you do not have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed maximum dosage) or decrease dose until you are comfortable age s tarting dos age maximum dos age adults and children 12 years and 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 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 6 mg (LOW SODIUM) store at room temperature 15° to 30°C (59° to 86°F) Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, tapioca starch , tartaric acid , titanium dioxide 1 Ques tions? call 1-888-838-2872, weekdays, 8 AM-5 PM Eastern Time This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Senokot-S Distributed by: GOLDLINE LABORATORIES, INC. Sellersville, PA 18960 Dist. 1999 0110REV 89 Additional barcode labeling by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146 PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle 1 1 may contain these ingredients † ®

Physicians Total Care, Inc. po lye thyle ne g lyc o l (UNII: 3WJQ 0 SDW1A) so dium be nz o a te (UNII: O J245FE5EU) ste a ric a c id (UNII: 4ELV7Z6 5AP) sta rc h, ta pio c a (UNII: 24SC3U70 4I) ta rta ric a c id (UNII: W48 8 8 I119 H) tita nium dio xide (UNII: 15FIX9 V2JP) a luminum o xide (UNII: LMI26 O 6 9 33) Product Characteristics Color O RANGE^ S core no sc o re S hap e RO UND (bi-c o nve x)^ S iz e 10 mm **Flavor Imp rint Cod e Contains Packag ing

Item Co de Packag e Descriptio n Marketing Start Date Marketing End Date

1** NDC:548 6 8 -49 17-0 10 0 in 1 BO TTLE, PLASTIC 2 NDC:548 6 8 -49 17-1 6 0 in 1 BO TTLE, PLASTIC

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 GRAPH NO T FINAL pa rt334 0 9 /11/20 0 3

Labeler - Phys icians T otal Care, Inc. (194123980)

Establishment

Name Ad d re s s ID/FEI Bus ine s s Op e rations Physic ia ns To ta l Ca re , Inc. 19 41239 8 0 re la be l Revised: 4/