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

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Senna-S Laxative

Active ingredients (in each tablet)

Docusate Sodium 50 mg

Sennosides 8.6 mg

Purpose

Stool softener

Stimulant laxative

Uses

  • relief of occasional constipation (irregularity).
  • generally causes bowel movement within 6 to 12 hours.

Warnings

Do not use if you are now taking mineral oil, unless directed by a doctor or laxative products for longer than 1 week, unless directed by a doctor.

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • a sudden change in bowel habits that lasts over a period of 2 weeks

Stop Use

Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after the use of a laxative. These may indicate a serious condition.

If pregnant or breast-feeding, ask a health care 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

  • taken preferably at bedtime or as directed by a doctor
Age
Starting Dose
Maximum Dosage
adults and children 12 years of age and older2 tablets once a day
4 tablets twice a day
children 6 to under 12 years of age1 tablet once a day
2 tablets twice a day
children 2 to 6 years of age1/2 tablet once a day
1 tablet twice a day
children under 2 yearsask a doctorask a doctor

Other information

  • each tablet contains: sodium 6 mg/tablet LOW SODIUM
  • each tablet contains: calcium 20 mg/tablet
  • store at 15°-30°C (59°-86°F),in well closed containers
  • do not use if imprinted safety seal under cap is broken or missing
  • *This product is not manufactured or distributed by Purdue Pharma L.P., owner of the registered trademark Senokot S.

Inactive ingredients

carnauba wax, croscarmellose sodium, DandC Yellow 10 Aluminum Lake, dibasic calcium phosphate dihydrate, FDandC Blue 2 Aluminum Lake*, FDandC Red 40 Aluminum Lake*, FDandC Yellow 6 Aluminum Lake, hypromellose, magnesium stearate, maltodextrin*, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol*, purified water*, silicon dioxide, sodium benzoate, stearic acid, talc*, and titanium dioxide   *may also contain

label

SENNA-S LAXATIVE 
docusate sodium, sennosides tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-561
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
DIBASIC CALCIUM PHOSPHATE 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
ColororangeScoreno score
ShapeROUNDSize10mm
FlavorImprint Code SS1;S35;TCL081
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51824-561-0160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/30/201206/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33404/30/201206/01/2016
Labeler - New World Imports, Inc. (075372276)

Revised: 8/2017
 
New World Imports, Inc.