SENOKOTXTRA- standardized senna concentrate tablet
Purdue Products LP

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SenokotXTRA
(standardized senna concentrate)

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 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.

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.

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

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

302602-0A

SenokotXTRA

12 Tablets

SENOKOTXTRA
standardized senna concentrate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67618-315
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:67618-315-12	1 in 1 CARTON	09/01/1988	12/31/2022
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:67618-315-36	3 in 1 CARTON	09/01/1988	01/01/2014
2		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	09/01/1988	12/31/2022

Labeler - Purdue Products LP (141916531)

Registrant - Purdue Pharma LP (932323652)

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

Revised: 9/2023

Document Id: 2c66fb30-7e35-65c0-395e-117a737b24ea

Set id: f27cb405-9820-4fe9-8432-e50643f2c7f0

Version: 3

Effective Time: 20230904

Purdue Products LP

SenokotXTRA (standardized senna concentrate)

Drug Facts Active ingredient (in each tablet) Purpose