SENNA LAXATIVE- sennosides tablet 
medsource pharmaceuticals

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

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

agestarting dosage maximum dosage 
 adults and children 12 years of age and over 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 tablets once a day 1 tablet twice a day
 children under 2 years ask a doctor ask a doctor


Other information

Inactive Ingredients

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

*contains one or more of these ingredients

Questions or comments?

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

Principal Display Panel

Senna Laxative

Standardized Senna Concentrate 8.6 mg

Natural Vegetable Laxative Ingredient

Gentle, overnight relief

†Compare to active ingredients in Senokot®

Tablets

†This product is not manufactured or distributed by Purdue Products L.P., distributor of Senokot®.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed By:

Geiss, Destin & Dunn, Inc.

Peachtree City, GA 30269

www.valuelabels.com

Product Label

pdp

SENNA LAXATIVE 
sennosides tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45865-965(NDC:50804-486)
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)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
Product Characteristics
ColorbrownScoreno score
ShapeROUNDSize9mm
FlavorImprint Code 0813;AV;TCL080;S8
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45865-965-3030 in 1 BOTTLE; Type 0: Not a Combination Product12/11/2019
2NDC:45865-965-6060 in 1 BOTTLE; Type 0: Not a Combination Product12/11/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/31/2016
Labeler - medsource pharmaceuticals (833685915)
Establishment
NameAddressID/FEIBusiness Operations
medsource pharmaceuticals833685915repack(45865-965)

Revised: 12/2019
Document Id: 9aefefe6-9608-368b-e053-2995a90a0de7
Set id: 9aefefcd-d1c3-f666-e053-2a95a90a8e82
Version: 1
Effective Time: 20191230
 
medsource pharmaceuticals