SENNA- sennosides tablet, film coated 
Cypress Pharmaceutical, Inc.

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

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 use 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
AgeStarting DosageMaximum Dosage
adults and children 12 years and older2 tablets once a day4 tablets twice a day
children 6 to under 12 years1 tablet once a day2 tablets twice a day
children 2 to under 6 years1/2 tablet once a day1 tablet twice a day
children under 2 yearsask a doctorask a doctor

Inactive Ingredients

Acacia gum, calcium carbonate, croscarmellose sodium, dextrose, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, propylene glycol, silicon dioxide, stearic acid, triacetin.

Other Information

  • each tablet contains: calcium 20 mg
  • store at room temperature 59° to 86°F (15° to 30°C).

Questions?

To report a Serious Adverse Event Call (800) 856-4393, M-F 8:00AM - 5:00PM CST

Contact Cypress Pharmaceutical, Inc. Madison, MS 39110.

Distributed by: Cypress Pharmaceutical, Inc., Madison, MS 39110

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

NDC 60258-950-01

Senna Laxative
Tablets

Natural Vegetable Laxative

EACH TABLET CONTAINS
Sennosides  8.6 mg

CYPRESS
PHARMACEUTICAL, INC.

100 Tablets

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
SENNA 
sennosides tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60258-950
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sennosides (UNII: 3FYP5M0IJX) (Sennosides - UNII:3FYP5M0IJX) Sennosides8.6 mg
Inactive Ingredients
Ingredient NameStrength
Acacia (UNII: 5C5403N26O)  
Calcium Carbonate (UNII: H0G9379FGK)  
Croscarmellose Sodium (UNII: M28OL1HH48)  
Dextrose (UNII: IY9XDZ35W2)  
Hypromelloses (UNII: 3NXW29V3WO)  
Magnesium Stearate (UNII: 70097M6I30)  
Maltodextrin (UNII: 7CVR7L4A2D)  
Cellulose, Microcrystalline (UNII: OP1R32D61U)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Triacetin (UNII: XHX3C3X673)  
Product Characteristics
ColorBROWNScore2 pieces
ShapeROUND (Biconvex) Size9mm
FlavorImprint Code GPI;W2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60258-950-01100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33406/07/200007/31/2016
Labeler - Cypress Pharmaceutical, Inc. (790248942)
Establishment
NameAddressID/FEIBusiness Operations
Gemini Pharmaceuticals055942270MANUFACTURE(60258-950)

Revised: 9/2015
Document Id: 07042115-fe98-445e-ab3a-cbdd12315c78
Set id: db3e09ed-aa54-4506-98df-8d07b6a4a1a1
Version: 1
Effective Time: 20150921
 
Cypress Pharmaceutical, Inc.