SENNA-S- senna and docusate sodium tablets, 8.6 mg and 50 mg tablet, coated 
HealthLife of USA LLC

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.

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Senna-S - Senna and Docusate Sodium Tablets, 8.6 mg & 50 mg

Drug Facts

Active ingredients Purpose (in each tablet)          Purpose

Docusate sodium 50 mg.......................................Stool softner

Sennosides 8.6 mg................................................Laxative

Uses

Warnings

Do not use

  • if you are now taking mineral oil, unless directed by a doctor
  • laxative products for longer than 1 week 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 lasts over 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.

If pregnant or breast-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

Other information

Inactive ingredients

croscarmellose sodium, colloidal silicon dioxide, dicalcium phosphate, D&C Yellow # 10, FD&C Yellow # 6, hypromellose, microcrystalline cellulose, magnesium stearate, maltodextrin, polyethylene glycol, stearic acid, titanium dioxide

Questions or comments?

Call toll free 1-844-832-1138 Monday through Friday 9AM – 5PM EST or www.healthlifeofusa.com

PRINCIPAL DISPLAY PANEL

Compare to the Active Ingredients in Senokot-S®

*This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Senokot-S®.

Senna and Docusate Sodium Tablets, 8.6 mg and 50 mg

Principal Display Panel

SENNA-S 
senna and docusate sodium tablets, 8.6 mg and 50 mg tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69517-131
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize10mm
FlavorImprint Code S35
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69517-131-2525 in 1 BOX04/08/2016
12 in 1 POUCH; Type 0: Not a Combination Product
2NDC:69517-131-5050 in 1 BOX04/08/2016
22 in 1 POUCH; Type 0: Not a Combination Product
3NDC:69517-131-022 in 1 POUCH04/08/2016
32 in 1 POUCH; Type 0: Not a Combination Product
4NDC:69517-131-101000 in 1 BOTTLE04/08/2016
4NDC:69517-131-05500 in 1 BOTTLE
4NDC:69517-131-2424 in 1 BOTTLE
41 in 1 CARTON; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/07/2016
Labeler - HealthLife of USA LLC (079656178)
Establishment
NameAddressID/FEIBusiness Operations
Elysium Pharmaceutical Ltd.915664486manufacture(69517-131)

Revised: 6/2017
Document Id: db488a26-b345-4a35-a311-1de16c5376d8
Set id: 02a5299c-4b0d-47ac-9838-afd0b0fdd4a6
Version: 8
Effective Time: 20170605
 
HealthLife of USA LLC