Senna Plus

SENNA - docusate sodium tablet 
NCS HealthCare of KY, Inc dba Vangard Labs

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Senna Plus

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 Plus Tablets (standardized senna concentrate equiv. to 8.6mg sennosides and docusate sodium 50mg,

SENNA 
senna plus   tablet
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)0615-5533 (0904-5512)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM50 mg
Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found
Product Characteristics
ColorORANGEScore no score
ShapeROUNDSize10mm
FlavorImprint Code CPC;490
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
10615-5533-3131 TABLET In 1 BLISTER PACKNone
20615-5533-3930 TABLET In 1 BLISTER PACKNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33407/01/2010

Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)
Establishment
NameAddressID/FEIOperations
NCS HealthCare of KY, Inc dba Vangard Labs050052943RELABEL, REPACK
Revised: 07/2010NCS HealthCare of KY, Inc dba Vangard Labs