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SENNA-S by Spirit Pharmaceuticals LLC

Dosage form: tablet
Ingredients: DOCUSATE SODIUM 50mg, SENNOSIDES 8.6mg
Labeler: Spirit Pharmaceuticals LLC
NDC Code: 68210-0302

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.

VALUMEDS SENNA-S

Drug Facts

Active ingredients (in each tablet)

Docusate sodium 50 mg
Sennosides 8.6 mg

Purpose

Stool Softner

Laxative

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6-12 hours

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 a period of 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
  • take preferably at bedtime or as directed by a doctor
 Age Starting Dosage Maximum Dosage
 adults and children 12 years of age or over 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 19.92 mg, sodium 5.61 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive ingredients

Colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C yellow No. 10, FD&C Yellow No. 6, hypromellose,magnesium stearate, microcrystalline cellulose, maltodextrin,polyethylene glycol-400, purified water, sodium benzoate, stearic acid, titanium dioxide

Questions or comments?

1-888-333-9792

Distributed By

Spirit Pharmaceuticals, LLC

Ronkonkoma, NY 11779

PRINCIPAL DISPLAY PANEL - 100 count bottle

VALUMEDS

Compare to the active ingredients in Senokot-S®*

SENNA-S

DOCUSATE SODIUM 50 mg

and SENNOSIDES 8.6 mg
NATURAL LAXATIVE

PLUS STOOL SOFTENER

100 TABLETS

SENNA-S 
docusate sodium and sennosides tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-0302
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM50 mg
SENNOSIDES (SENNOSIDES) SENNOSIDES8.6 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
FD&C YELLOW NO. 6 
D&C YELLOW NO. 10 
HYPROMELLOSE, UNSPECIFIED 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
MALTODEXTRIN 
POLYETHYLENE GLYCOL 400 
WATER 
SODIUM BENZOATE 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColororangeScoreno score
ShapeROUND (biconvex) Size10mm
FlavorImprint CodeS35
Contains    
Packaging
#Item CodePackage Description
1NDC:68210-0302-1100 TABLET in 1 BOTTLE
2NDC:68210-0302-31 BOTTLE in 1 CARTON
230 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33405/19/2017
Labeler - Spirit Pharmaceuticals LLC (179621011)
Establishment
NameAddressID/FEIOperations
Elysium Pharmaceuticals LTD915664486manufacture(68210-0302)

 
Spirit Pharmaceuticals LLC

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Medically reviewed on Apr 11, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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