SENNA-S LAXATIVE- docusate sodium and sennosides tablet, coated 
New World Imports

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 Facts

Active ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

Purpose

Stool softener

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 (1-800-222-1222).

Directions

 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
 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

Inactive ingredients

carnauba wax*, croscarmellose sodium, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake*, FD&C red #40 aluminum lake*, FD&C yellow #6 aluminum lake, hypromellose*, magnesium stearate, maltodextrin*, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol*, purified water*, silicon dioxide, sodium benzoate*, stearic acid, talc*, titanium dioxide

*contains one or more of these ingredients

Principal Display Panel

Compare to the active ingredients of Senokot-S®†

Senna-S Laxative

Natural Vegetable Laxative

Stool Softener Plus Laxative

Docusate Sodium, 50 mg

Sennosides, 8.6 mg Tablets

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

Distributed By:

NWI, Inc 160 Athens Way
Nashville, TN 37228

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Package Label

 Sennosides 8.6 mg

New World Imports Senna S Laxative Tablets

SENNA-S LAXATIVE 
docusate sodium, sennosides tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51824-561
Route of Administration ORAL DEA Schedule     
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
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
WATER (UNII: 059QF0KO0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code SS1;S35;TCL081
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:51824-561-01 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 04/30/2012
Labeler - New World Imports (075372276)

Revised: 11/2013
Document Id: 6a6f768f-5fa1-4cd0-96ae-a48bd82dffc8
Set id: 56e5045b-78ae-4169-b566-7b29f9f03cec
Version: 6
Effective Time: 20131113
 
New World Imports