SENNA PLUS- sennosides and docusate sodium tablet
NCS HealthCare of KY, LLC dba Vangard Labs

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Senna Plus

Active ingredient (in each tablet)

Sennosides from Senna Concentrate 8.6 mg

Sodium Dioctylsulfosuccinate 50 mg

Purpose

Laxetive

Stool Softener

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.

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 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
sennosides and docusate sodium tablet

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

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

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STARCH, TAPIOCA (UNII: 24SC3U704I)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STEARIC ACID (UNII: 4ELV7Z65AP)
TARTARIC ACID (UNII: W4888I119H)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND (bi-convex)	Size	10mm
Flavor		Imprint Code	CPC;490
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0615-5533-39	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	06/16/2011	04/30/2015
2	NDC:0615-5533-31	31 in 1 BLISTER PACK; Type 0: Not a Combination Product	06/16/2011	04/30/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	06/16/2011	04/30/2015

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

Name	Address	ID/FEI	Business Operations
Establishment
NCS HealthCare of KY, LLC dba Vangard Labs		050052943	repack(0615-5533)

Revised: 8/2021

Document Id: d9719fc2-003a-462a-9dd6-b0eb04e640be

Set id: 84d93cbc-4c9e-4db4-8d81-9e5221a3623f

Version: 12

Effective Time: 20210831

NCS HealthCare of KY, LLC dba Vangard Labs