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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Drug Facts

Active ingredient (in each tablet)

Sennosides 8.6 mg

Purpose

Laxative

Uses

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

age starting dosage maximum 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

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

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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 Type HUMAN OTC DRUG Item Code (Source) NDC:51645-851
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES 8.6 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
SODIUM SULFATE (UNII: 0YPR65R21J)  
HYPROMELLOSES (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
Color brown Score 2 pieces
Shape ROUND (Biconvex) Size 9mm
Flavor Imprint Code GPI;W2
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:51645-851-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2 NDC:51645-851-10 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3 NDC:51645-851-99 10 in 1 CARTON
3 10 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 03/27/2006
Labeler - Gemini Pharmaceuticals, Inc. dba Plus Pharma (055942270)
Registrant - Gemini Pharmaceuticals, Inc. dba Plus Pharma (055942270)
Establishment
Name Address ID/FEI Business Operations
Gemini Pharmaceuticals, Inc. dba Plus Pharma 055942270 manufacture(51645-851)

Revised: 3/2006
Document Id: 69957d96-0528-4707-b412-59cf1fe5a9b3
Set id: 4ff7e9fb-099a-40d1-afd7-cd1607885c0d
Version: 4
Effective Time: 20060327
 
Gemini Pharmaceuticals, Inc. dba Plus Pharma