Active ingredient(s)

Sennosides from Senna Concentrate 8.6mg

Docusate Sodium 50mg

Purpose

Laxetive

Stool Softener

Use(s)

-fort the short term relief of constipation

-products bowel movement in 6 to 12 hours

Warnings

Contains FD&C Yellow #5 Lake (Tartrazine) as a color additive

Do not use

-for longer than one week

-when abdominal pain, neusea, or vomiting are present

Ask a doctor or pharmacist before use if

-you have noticed a sudden change in bowel habits that lasts over a period of two weeks

Stop use and ask a doctor if

-you have rectal bleeding

-you fail to have a bowel movement after use of this product, this may indicate a serious condition

Pregnancy/Breastfeeding

ask a health care 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 preferrably at bedtime or as directed by a doctor

-If you do not have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed the maximum dosage or decrease dose until you are comfortable

age starting dosage maximum dosage

-adults and children over 12 years 2 tablets once a day 4 tablets twice a day

-children 6 to 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 do not use

Storage

Store at room temperature, USP

Inactive ingredients

Croscarmellose Sodium, Dicalcium Phosphate, FD&C Yellow #5 Lake, FD&C Yellow #6 Lake, Hypromellose, Magnesium Silicate, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil, Polyethylene Glycol, Sodium Benzoate, Starch, Stearic Acid and Titanium Dioxide.

Questions

Serious Adverse Effects Call: (800) 616-2471

This product is not manufactured or distributed by Purdue Pharma L.P. owner of the registered trademark Senokto-S

Distributed by: Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48150

Rev. 02/08

M-29

Principal Display Panel

Senna Plus Tablets

(Standardized senna concentrate equiv. to

8.6mg sennosides and docusate sodium 50mg)

SENNA
senna plus tablet

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	0615-5533 (0904-5512)
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (DOCUSATE)	DOCUSATE SODIUM	50 mg

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color	ORANGE	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	CPC;490
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0615-5533-31	31 TABLET In 1 BLISTER PACK	None
2	0615-5533-39	30 TABLET In 1 BLISTER PACK	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part334	07/01/2010

Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)

Establishment
Name	Address	ID/FEI	Operations
NCS HealthCare of KY, Inc dba Vangard Labs		050052943	RELABEL, REPACK

Revised: 07/2010NCS HealthCare of KY, Inc dba Vangard Labs