PLUS PHARMA SENNA STANDARDIZED SENNA CONCENTRATE 8.6 MG SENNOSIDES EACH- 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 Tablets

Active ingredient (in each tablet)

Sennosides 8.6 mg

Purpose

Laxative

Uses

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

Warnings


Do not use

  • 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 dosagemaximum dosage
adults and children 12 years of age and older
2 tablets once a day
4 tablets twice a day
children 6 to under 12 years of age
1 tablet once a day
2 tablets twice a day
children 2 to under 6 years of age
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
  • Store at room temperature
  • Do not use if imprinted seal under cap is broken or missing

Inactive ingredients

Calcium carbonate, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, propylene glycol, silicon dioxide, sodium sulfate, stearic acid, triacetin.

Questions?

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

Principal Display Panel

NDC 51645-851-01

PlusPHARMA

Senna

Standardized Senna Concentrate

8.6 mg Sennosides Each

Natural Vegetable Laxative Ingredient

*Compare to Senokot®

Product color may vary slightly due to nature of ingredients.

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

100 TABLETS

kjylued.jpg



NDC 51645-851-10

PlusPHARMA

Senna

Standardized Senna Concentrate

8.6 mg Sennosides Each

Natural Vegetable Laxative Ingredient

*Compare to Senokot®

Product color may vary slightly due to nature of ingredients.

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

1000 TABLETS

mjhleted.jpg

NDC 51645-851-99

PlusPHARMA

Unit Dose

Senna

(Standardized Senna Concentrate)

Sennosides 8.6 mg

100 TABLETS (10x10)

*Compare to the Active ingredient in Senokot®

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



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PLUS PHARMA SENNA  STANDARDIZED SENNA CONCENTRATE 8.6 MG SENNOSIDES EACH
sennosides tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51645-851
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
SODIUM SULFATE (UNII: 0YPR65R21J)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorbrownScore2 pieces
ShapeROUND (Biconvex) Size9mm
FlavorImprint Code GPI;W2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51645-851-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/200610/31/2021
2NDC:51645-851-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/200610/31/2021
3NDC:51645-851-9910 in 1 CARTON03/27/200612/31/2020
310 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/27/200610/31/2021
Labeler - Gemini Pharmaceuticals, Inc. dba Plus Pharma (055942270)
Establishment
NameAddressID/FEIBusiness Operations
Gemini Pharmaceuticals, Inc. dba Plus Pharma 055942270manufacture(51645-851)

Revised: 9/2022
 
Gemini Pharmaceuticals, Inc. dba Plus Pharma