PLUS PHARMA SENNA PLUS STANDARDIZED SENNA CONCENTRATE 8.6 MG AND DOCUSATE SODIUM 50 MG EACH- docusate sodium,sennosides tablet, film coated 
Gemini Pharmaceuticals, Inc. dba Plus Pharma

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 Plus Tablets

Drug Facts

Active ingredients (in each tablet)

Docusate Sodium 50 mg

Sennosides 8.6 mg

Purposes

Stool softener

Laxative

Uses

  • relieves occasional constipation (irregularity)
  • generally produces a 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 continues 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.

Directions

  • take preferably at bedtime or as directed by a doctor
agestarting dosemaximum dose
adults and children 12 years and older
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 20 mg
  • each tablet contains: sodium4 mg
  • store at room temperature in a dry place
  • keep lid tightly closed

Inactive ingredients Croscarmellose sodium, D&C yellow #10, dextrose, dicalcium phosphate, FD&C yellow #6, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silica, sodium benzoate, stearic acid, titanium dioxide.

Questions? If you have any questions or comments, or to report an adverse event, please contact (800) 795-9775.

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by:

Plus Pharma

Commack, NY 11725

Manufactured in a GMP facility in the USA

NDC 51645-850-10

Plus PHARMA

Senna Plus

Standardized Senna Concentrate 8.6 mg and Docusate Sodium 50 mg Each

Vegetable Laxative Ingredient Plus Stool Softener

Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).

*Compare to the Active Ingredients in Senokot-S®

*Plus Pharma is not affiliated with the owner of the registered trademark Senokot-S®

1000 TABLETS

Plus Pharma Senna Plus

PLUS PHARMA SENNA PLUS  STANDARDIZED SENNA CONCENTRATE 8.6 MG AND DOCUSATE SODIUM 50 MG EACH
docusate sodium,sennosides tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51645-850
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
DEXTROSE (UNII: IY9XDZ35W2)  
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColororangeScoreno score
ShapeROUND (Biconvex) Size10mm
FlavorImprint Code G55
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51645-850-0660 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/200603/31/2022
2NDC:51645-850-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/200607/31/2020
3NDC:51645-850-9910 in 1 CARTON03/27/200607/31/2020
310 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:51645-850-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/200606/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/27/200603/31/2022
Labeler - Gemini Pharmaceuticals, Inc. dba Plus Pharma (055942270)
Establishment
NameAddressID/FEIBusiness Operations
Gemini Pharmaceuticals, Inc. dba Plus Pharma055942270manufacture(51645-850)

Revised: 11/2020
Document Id: b3db6ed6-cbc5-d23a-e053-2995a90ad052
Set id: 55e6350a-cdeb-4aba-9f7a-d9ddf7c1b3cf
Version: 5
Effective Time: 20201111
 
Gemini Pharmaceuticals, Inc. dba Plus Pharma