SENNA NATURAL VEGETABLE LAXATIVE- sennosides tablet 
Chain Drug Consortium, LLC

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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DRUG FACTS

Active ingredient (in each tablet)

Sennosides 8.6 mg

Purpose

Laxative

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

Ask a doctor before using 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.

Directions

  • take preferably at bedtime or as directed by a doctor

 age

 starting dosage maximum dosage
 adults and children 12 years of age or 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


Other information


  • each tablet contains: calcium 25 mg
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive ingredients

croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, liquid paraffin*, magnesium stearate, maltodextrin*, microcrystalline cellulose, mineral oil*, silicon dioxide*, stearic acid*, sodium lauryl sulfate*, talc*, triacetin*

*contains one or more of these ingredients

Questions or comments?

Call toll free: 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

**COMPARE TO THE ACTIVE INGREDIENT IN SENOKOT®

Senna

STANDARDIZED SENNA CONCENTRATE NATURAL VEGETABLE LAXATIVE

SENNOSIDES 8.6 mg

Relieves Occasional Constipation

TABLETS

**This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Senokot®

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

DISTRIBUTED BY:

CHAIN DRUG CONSORTIUM, LLC.

3301 NW BOCA RATON BLVD. SUITE 101

BOCA RATON, FL  33431

Product Labeling

Sennosides 8.6 mg

Premier Value Senna Standardized Senna Concentrate Natural Vegetable Laxative

SENNA  NATURAL VEGETABLE LAXATIVE
sennosides tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-278
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TRIACETIN (UNII: XHX3C3X673)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Product Characteristics
ColorBROWNScoreno score
ShapeROUNDSize9mm
FlavorImprint Code S3;TCL080;S8
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-278-001 in 1 BOX07/01/201012/31/2020
1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33407/01/201012/31/2020
Labeler - Chain Drug Consortium, LLC (101668460)
Registrant - P & L Development, LLC (800014821)

Revised: 12/2018
Document Id: e3d6e5dc-1de7-4ea1-a612-9a4973d05774
Set id: 7198659c-f23c-4c23-9d33-97d4afdff64f
Version: 4
Effective Time: 20181206
 
Chain Drug Consortium, LLC