SENNA-S- sennosides and docusate sodium tablet 
Chain Drug Consortium, 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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pv 455

Active ingredient (in each tablet)

Docusate Sodium 50 mg
Sennosides 8.6 mg

Purpose

Stool softener

Laxative

Uses

  • relieves occasional constipation (irregularity)
  • this product generally produces a bowel movement in 6 to 12 hours

Warnings

Do not use for more than 1 week unless directed by a doctor

Ask a doctor before use if you

  • have abdominal pain, nausea or vomiting
  • are taking mineral oil
  • have noticed a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if you have

  • no bowel movement within 12 hours
  • rectal bleeding
  • these could signs of 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

• do not exceed 8 tablets in 24 hours

Age
Starting Dose
Maximum Dose
adults and children 12 years of age and older
2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor
4 tablets in the morning and 4 tablets at bedtime
children under 12 years
ask a doctor

Other information

  • each tablet contains: calcium 20 mg, sodium 6 mg
  • store at room temperature 15° - 30°C (59°-86°F)

Inactive ingredients

cellulose, croscarmellose sodium, dicalcium phosphate, D&C yellow
#10, FD&C yellow #6, hypromellose, magnesium stearate, PEG, silica, sodium benzoate, stearic acid,
titanium dioxide, wax.

Package Label

5

SENNA-S 
sennosides and docusate sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-746
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
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize9mm
FlavorImprint Code TCL081
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-746-601 in 1 CARTON05/01/2017
160 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33405/01/201706/01/2023
Labeler - Chain Drug Consortium, LLC (101668460)
Registrant - Geri-Care Pharmaceutical Corp (611196254)
Establishment
NameAddressID/FEIBusiness Operations
Geri-Care Pharmaceutical Corp611196254repack(68016-746)

Revised: 12/2021
Document Id: d22f1cff-1135-97b0-e053-2995a90a1b87
Set id: 61f84b81-99fb-626d-e053-2a91aa0a8b83
Version: 3
Effective Time: 20211202
 
Chain Drug Consortium, LLC