STOOL SOFTENER WITH LAXATIVE- docusate sodium and sennosides tablet, film coated 
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 303

Active ingredient (in each tablet)

Docusate Sodium 50 mg
Sennosides 8.6 mg

Purpose

Stool softener

Stimulant laxative

Uses

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

Warnings

Do not use

  • laxative products for longer than 1 week unless directed by a doctor
  • if you are presently taking mineral oil, 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 could

be 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

  • Take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses

adults and children 12 years and overtake 2-4 tablets daily
children 6 to under 12 years of agetake 1-2 tablets daily
children under 6 years of ageask a doctor

Other information

  • each tablet contains: calcium 20 mg
  • each tablet contains: sodium 6 mg VERY LOW SODIUM
  • store at 15°-30°C (59°-86°F), protect from excessive moisture
  • Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C red #40 aluminum lake, hypromellose, magnesium
stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, titanium dioxide

Questions or comments?

Call toll free 1-800-540-3765

Package Label

PV303

STOOL SOFTENER WITH LAXATIVE 
docusate sodium and sennosides tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-622
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
CARNAUBA WAX (UNII: R12CBM0EIZ)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
ColorredScoreno score
ShapeROUNDSize10mm
FlavorImprint Code TCL097
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-622-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/01/2014
2NDC:68016-622-25250 in 1 BOTTLE; Type 0: Not a Combination Product11/01/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33411/01/201406/01/2021
Labeler - Chain Drug Consortium, LLC (101668460)
Registrant - Geri-Care Pharmaceutical Corp (611196254)
Establishment
NameAddressID/FEIBusiness Operations
Geri-Care Pharmaceuticals, Corp611196254repack(68016-622)

Revised: 12/2021
 
Chain Drug Consortium, LLC