SENOKOT- standardized senna concentrate tablet, film coated

Senokot by

Drug Labeling and Warnings

Senokot by is a Otc medication manufactured, distributed, or labeled by Avrio Health L.P., Purdue Pharma LP, Contract Pharmacal Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active ingredient (in each tablet) Purpose

Sennosides 17.2 mg

PURPOSE

Purpose

Laxative

WHEN USING

Uses

• relieves occasional constipation (irregularity)
• generally causes bowel movement in 6-12 hours

WARNINGS

Warnings

DO NOT USE

Do not use

• laxative products for longer than 1 week unless directed by a doctor

ASK DOCTOR

Ask a doctor before use if you have

• stomach pain
• nausea
• vomiting
• noticed a sudden change in bowel movements that continues over a period of 2 weeks

STOP USE

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.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• take preferably at bedtime or as directed by a doctor

DOSAGE FORMS & STRENGTHS

age	starting dosage	maximum dosage
adults and children 12 years of age and over	1 tablet once a day	2 tablets twice a day
children 6 to under 12 years	1/2 tablet once a day	1 tablet twice a day
children under 6	ask a doctor	ask a doctor

QUESTIONS

Other information

• each tablet contains: calcium 20 mg
• store at 25˚C (77˚F); excursions permitted between 15˚-30˚C (59˚-86˚F)

INACTIVE INGREDIENT

Inactive ingredients croscarmellose sodium, dicalcium phosphate, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, mineral oil, stearic acid, talc, tartaric acid

©2018, Avrio Health L.P. Stamford, CT 06901-3431

INDICATIONS & USAGE

PRINCIPAL DISPLAY PANEL

Senokot® Extra Strength
NDC: 67618-120-12

PRINCIPAL DISPLAY PANEL

Senokot® Extra Strength
NDC: 67618-120-36

INGREDIENTS AND APPEARANCE

SENOKOT 
standardized senna concentrate tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67618-120
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	17.2 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
TARTARIC ACID (UNII: W4888I119H)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	BROWN (Light Brown)	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	X
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67618-120-12	1 in 1 CARTON	09/01/1988
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 67618-120-36	3 in 1 CELLO PACK	09/01/1988
2		12 in 1 BLISTER PACK
2		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 67618-120-06	36 in 1 BOTTLE; Type 0: Not a Combination Product	09/01/1988

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	09/01/1988

Labeler - Avrio Health L.P. (141916531)

Registrant - Purdue Pharma LP (932323652)

Establishment
Name	Address	ID/FEI	Business Operations
Contract Pharmacal Corporation		968334974	MANUFACTURE(67618-120)