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Senna Plus

NCS HealthCare of KY, Inc dba Vangard Labs

Senna Plus


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Sennosides from Senna Concentrate 8.6 mg

Sodium Dioctylsulfosuccinate 50 mg

Purpose

Laxetive

Stool Softener

Senna Plus 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

• if you are now taking mineral oil, unless directed by a doctor

Ask a doctor before use if you have

• stomache 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 care professional before use. 

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 over 12 years 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 under 6 years ask a doctor  

Other Information

Store at room temperature, USP

Other 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, Sodium Lauryl Sulfate, Starch, Stearic Acid, Titanium Dioxide and Triacetin.

Questions

Serious Adverse Effects Call: (800) 616-2471

**WARNING: Contains FD&C Yellow #5 Lake (Tartrazine) as a color additive.

*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, USA

Rev. 04/11 M-29

Principal Display Panel

Senna Plus Tablets

(Standardized senna concentrate equiv. to

8.6mg sennosides and sodium dioctylsulfosuccinate 50mg)

Senna Plus

Senna Plus

Sennosides and Docusate Sodium TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0615-5533(NDC:0904-5512)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM DOCUSATE 50 mg
SENNOSIDES SENNOSIDES 8.6 mg

Inactive Ingredients

Ingredient Name Strength
CROSCARMELLOSE SODIUM
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
FD&C YELLOW NO. 5
FD&C YELLOW NO. 6
HYPROMELLOSES
magnesium silicate
MAGNESIUM STEARATE
cellulose, microcrystalline
Mineral Oil
SODIUM BENZOATE
SODIUM LAURYL SULFATE
STARCH, TAPIOCA
POLYETHYLENE GLYCOLS
titanium dioxide
STEARIC ACID
tartaric acid
triacetin

Product Characteristics

Color Size Imprint Code Shape
ORANGE 10 mm CPC;490 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0615-5533-31 31 in 1 BLISTER PACK
2 NDC:0615-5533-39 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2011-06-16


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Be sure to consult your doctor before taking any medication!
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