SENNA-LAX- senna-lax tablet 
SENNA- senna tablet, coated 
DirectRX

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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

Age Starting dosage Maximum dosage
Adults and children over 12 years 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 tablet once a day 1 tablet twice a day
children under 2 years consult 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

205

425-60

SENNA-LAX 
senna-lax tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61919-205(NDC:0603-0282)
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
LACTOSE (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
TARTARIC ACID (UNII: W4888I119H)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorbrownScoreno score
ShapeROUNDSize3mm
FlavorImprint Code AZ217
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61919-205-3030 in 1 BOTTLE; Type 0: Not a Combination Product01/01/201510/09/2023
2NDC:61919-205-6060 in 1 BOTTLE; Type 0: Not a Combination Product01/01/201510/09/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02201/01/201510/09/2023
SENNA 
senna tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61919-425(NDC:0904-6434)
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
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
Product Characteristics
ColorbrownScoreno score
ShapeROUNDSize9mm
FlavorImprint Code TCL080
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61919-425-6060 in 1 BOTTLE; Type 0: Not a Combination Product03/07/201910/09/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02203/07/201910/09/2023
Labeler - DirectRX (079254320)
Registrant - DirectRX (079254320)
Establishment
NameAddressID/FEIBusiness Operations
DirectRX079254320repack(61919-205, 61919-425)

Revised: 10/2023
 
DirectRX