SENNA-LAX- sennosides a and b tablet, film coated 
Lake Erie Medical DBA Quality Care Products 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 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 of age and older
2 tablets once a day
4 tablets twice a day
children 6 to under 12 years of age
1 tablet once a day
2 tablets twice a day
children 2 to under 6 years of age
1/2 tablet once a day
1 tablet twice a day
children under 2 years of age
ask a doctor
ask a doctor

Other information

  • Each tablet contains: Calcium 20 mg
  • Store at room temperature

Inactive ingredients

Acacia Gum, Calcium Carbonate, Croscarmellose Sodium, Dextrose, Hypromellose, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Propylene Glycol, Silicon Dioxide, Stearic Acid, Triacetin.

Questions?

Adverse Drug Event call (800) 616-2471

image description

SENNA-LAX 
sennosides a and b tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55700-128(NDC:0904-5165)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN) SENNOSIDES A AND B8.6 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:55700-128-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/04/201410/11/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33405/04/201110/11/2019
Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758)
Establishment
NameAddressID/FEIBusiness Operations
Lake Erie Medical DBA Quality Care Products LLC831276758repack(55700-128)

Revised: 11/2019
Document Id: d6b8f62b-1396-40bc-a0d5-737d0d2a6317
Set id: ab227c4a-c983-4532-8be6-a120f5d8d149
Version: 3
Effective Time: 20191104
 
Lake Erie Medical DBA Quality Care Products LLC