Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

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

age	starting dosage	maximum 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

SENNA-LAX 
sennosides a and b tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55700-128(NDC: 0904-5165)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN)	SENNOSIDES A AND B	8.6 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	brown	Score	2 pieces
Shape	ROUND (Biconvex)	Size	9mm
Flavor		Imprint Code	GPI;W2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55700-128-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/04/2014	10/11/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	05/04/2011	10/11/2019

Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758)

Establishment
Name	Address	ID/FEI	Business Operations
Lake Erie Medical DBA Quality Care Products LLC		831276758	repack(55700-128)

Revised: 11/2019

Document Id: d6b8f62b-1396-40bc-a0d5-737d0d2a6317

34390-5

Set id: ab227c4a-c983-4532-8be6-a120f5d8d149

Version: 3

Effective Time: 20191104

 

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