PLUS PHARMA SENNA PLUS STANDARDIZED SENNA CONCENTRATE 8.6 MG AND DOCUSATE SODIUM 50 MG EACH- docusate sodium,sennosides tablet, film coated

Plus Pharma Senna Plus by

Drug Labeling and Warnings

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

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each tablet)

Docusate Sodium 50 mg

Sennosides 8.6 mg

PURPOSE

Purposes

Stool softener

Laxative

INDICATIONS & USAGE

Uses

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

WARNINGS

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.

DOSAGE & ADMINISTRATION

Directions

• take preferably at bedtime or as directed by a doctor

age	starting dose	maximum 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

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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 INGREDIENT

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

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

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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

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51645-850
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	8.6 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	orange	Score	no score
Shape	ROUND (Biconvex)	Size	10mm
Flavor		Imprint Code	G55
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51645-850-06	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2006
2	NDC: 51645-850-10	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2006
3	NDC: 51645-850-99	10 in 1 CARTON	03/27/2006
3		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 51645-850-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2006

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(51645-850)