SENOKOTXTRA- standardized senna concentrate tablet

SenokotXTRA by

Drug Labeling and Warnings

SenokotXTRA by is a Otc medication manufactured, distributed, or labeled by Purdue Products LP, Purdue Pharma LP, Contract Pharmacal Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts Active ingredient (in each tablet) Purpose

Sennosides 17.2 mg

Purpose

Laxative

Uses

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

Warnings

Do not use

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

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	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

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

SPL UNCLASSIFIED SECTION

©2011, Purdue Products L.P.

Dist. by: Purdue Products L.P., Stamford, CT 06901-3431

302602-0A

PRINCIPAL DISPLAY PANEL

SenokotXTRA

12 Tablets

INGREDIENTS AND APPEARANCE

SENOKOTXTRA 
standardized senna concentrate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67618-315
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)
anhydrous lactose (UNII: 3SY5LH9PMK)
magnesium stearate (UNII: 70097M6I30)
cellulose, microcrystalline (UNII: OP1R32D61U)
mineral oil (UNII: T5L8T28FGP)
stearic acid (UNII: 4ELV7Z65AP)
tartaric acid (UNII: W4888I119H)
hypromelloses (UNII: 3NXW29V3WO)
anhydrous dibasic calcium phosphate (UNII: L11K75P92J)

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: 67618-315-12	1 in 1 CARTON	09/01/1988
1		12 in 1 BLISTER PACK
2	NDC: 67618-315-36	3 in 1 CARTON	09/01/1988	01/01/2014
2		12 in 1 BLISTER PACK

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

Labeler - Purdue Products LP (141916531)

Registrant - Purdue Pharma LP (932323652)

Establishment
Name	Address	ID/FEI	Business Operations
Contract Pharmacal Corporation		968334974	MANUFACTURE(67618-315)