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SENNA-LAX by DirectRX

Medically reviewed on November 14, 2016

Dosage form: tablet
Ingredients: SENNOSIDES A AND B 8.6mg
Labeler: DirectRX
NDC Code: 61919-205

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.

SENNA-LAX

OTC - ACTIVE INGREDIENT SECTION

Sennosides 8.6 mg

OTC - PURPOSE SECTION

Laxative-•for relief of occasional constipation and irregularity •this product produces a bowel movement in 6 to 12 hours

WARNINGS SECTION
  • Do Not Use

    laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor

    Ask a doctor before use if you have

    noticed a sudden change in bowel habits that persists over a period of 2 weeks

    Ask a Doctor/Pharmacist before use if you are

    taking a prescription drug. Laxatives may affect how other drugs work. Take this product 2 or more hours before or after other drugs.

    When Using this product

    do not use for longer than 1 week unless directed by a doctor

    Stop Use and ask a doctor

    rectal bleeding or failure to have a bowel movement occur after use of a laxative. These could be signs of 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.

DOSAGE & ADMINISTRATION SECTION
  • • Take preferably at bedtime or as directed by doctor • If you do not have a comfortable bowel movement by the second day, increase dose by 1 tablet (do not exceed maximum dosage) or decrease dose until you are comfortable

    AgeStarting dosageMaximum dosage
    Adults and children over 12 years2 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 yearsconsult a doctor

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate (dehydrate), lactose, magnesium stearate, microcrystalline cellulose, tartaric acid.

INDICATIONS & USAGE SECTION

•for relief of occasional constipation and irregularity •this product produces a bowel movement in 6 to 12 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SENNA-LAX 
senna-lax tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61919-205(NDC:0603-0282)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNOSIDES A AND B (SENNOSIDES A AND B) SENNOSIDES A AND B8.6 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
LACTOSE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
TARTARIC ACID 
Product Characteristics
ColorbrownScoreno score
ShapeROUNDSize3mm
FlavorImprint CodeAZ217
Contains    
Packaging
#Item CodePackage Description
1NDC:61919-205-3030 TABLET in 1 BOTTLE
2NDC:61919-205-6060 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/01/2015
Labeler - DirectRX (079254320)
Establishment
NameAddressID/FEIOperations
DirectRX079254320repack(61919-205)

 
DirectRX

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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