SENOKOT- standardized senna concentrate tablet

Senokot by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts
Active ingredient (in each tablet)

Sennosides 8.6 mg

PURPOSE

Laxative

INDICATIONS & USAGE

Uses

• relieves occasional constipation (irregularity)
• generally produces a 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/PHARMACIST

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

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

age	starting dosage	maximum dosage
adults and children; 12 years of age and over	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	ask a doctor	ask a doctor

SPL UNCLASSIFIED SECTION

Other Information

• each tablet contains: calcium 10 mg
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

INACTIVE INGREDIENT

Inactive ingredients

dicalcium phosphate, magnesium stearate, microcrystalline cellulose, pregelatinized starch

SPL UNCLASSIFIED SECTION

©2018

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

305018-0A

PRINCIPAL DISPLAY PANEL

100 Tablets

PRINCIPAL DISPLAY PANEL

100 Tablets & 50 Tablets 2 pack

PRINCIPAL DISPLAY PANEL

100 Tablets & 50 Tablets Dual pack

INGREDIENTS AND APPEARANCE

SENOKOT 
standardized senna concentrate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67618-300
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	8.6 mg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	BROWN	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	S
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67618-300-40	1 in 1 CARTON	06/01/1956	12/31/2016
1		4 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 67618-300-24	3 in 1 CARTON	06/01/1956	12/31/2016
2		24 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 67618-300-20	2 in 1 CARTON	06/01/1956
3		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 67618-300-50	1 in 1 CARTON	06/01/1956
4		50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
5	NDC: 67618-300-10	1 in 1 CARTON	06/01/1956
5		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
6	NDC: 67618-300-04	4 in 1 BLISTER PACK; Type 0: Not a Combination Product	06/01/1956	12/31/2016
7	NDC: 67618-300-15	2 in 1 CARTON	06/01/1956
7		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	06/01/1956

SENOKOT 
standardized senna concentrate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67618-371
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	8.6 mg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	BROWN	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67618-371-00	2 in 1 CELLO PACK	06/01/1956
1		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	06/01/1956

Labeler - Avrio Health L.P. (141916531)

Registrant - Purdue Pharma LP (932323652)

Establishment
Name	Address	ID/FEI	Business Operations
Purdue Pharma		250955291	MANUFACTURE(67618-371, 67618-300)