SENNA-LAX tablet SENNA tablet, coated

SENNA by

Drug Labeling and Warnings

SENNA by is a Otc medication manufactured, distributed, or labeled by DirectRX. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SENNA-LAX 
senna-lax tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61919-205(NDC: 0603-0282)
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
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)

Product Characteristics
Color	brown	Score	no score
Shape	ROUND	Size	3mm
Flavor		Imprint Code	AZ217
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61919-205-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2015
2	NDC: 61919-205-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	01/01/2015

SENNA 
senna tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61919-425(NDC: 0904-6434)
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
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
Color	brown	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	TCL080
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61919-425-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	03/07/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	03/07/2019

Labeler - DirectRX (079254320)

Registrant - DirectRX (079254320)

Establishment
Name	Address	ID/FEI	Business Operations
DirectRX		079254320	repack(61919-205, 61919-425)