PLUS PHARMA SENNA STANDARDIZED SENNA CONCENTRATE 8.6 MG SENNOSIDES EACH- sennosides tablet, film coated

Plus Pharma Senna by

Drug Labeling and Warnings

Plus Pharma Senna by is a Otc medication manufactured, distributed, or labeled by Gemini Pharmaceuticals, Inc. dba Plus Pharma, Gemini Pharmaceuticals, Inc. dba Plus Pharma . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

• 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

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

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®.

INGREDIENTS AND APPEARANCE

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)
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
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	03/27/2006
2	NDC: 51645-851-10	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2006
3	NDC: 51645-851-99	10 in 1 CARTON	03/27/2006
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)

Establishment
Name	Address	ID/FEI	Business Operations
Gemini Pharmaceuticals, Inc. dba Plus Pharma		055942270	manufacture(51645-851)