SENNA LAXATIVE- sennosides tablet, coated
NCS HealthCare of KY, LLC dba Vangard Labs

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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Senna Tablets

Active ingredient (in each tablet)

Sennosides 8.6mg

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 perferably at bedtime or as directed by a doctor

If you do not have a comforable bowel movement by the second day, increase dose by one tablet (do not exceed maximum dosage) or decrease dose until you are comforable.

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	ask a doctor	ask a doctor

Other information

Each tablet contains: calcium 25mg, sodium 2mg, VERY LOW SODIUM

store at 25ºC (77ºF) excursions permitted between 15º - 30ºC (59º - 86ºF)

Inactive ingredients

Croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil

Questions

To Report Adverse Drug Event Call: (800) 616-2471

Distributed by MAJOR PHARMACEUTICALS

31778 Enterprise Drive

Livonia, MI 48150

Principal Display Panel

Senna Tablets

SENNA LAXATIVE
sennosides tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0615-4529(NDC:0904-5165)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN)	SENNOSIDES A AND B	8.6 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)

Product Characteristics
Color	brown	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	TCL;080
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0615-4529-39	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	05/24/2011	06/30/2017
2	NDC:0615-4529-31	31 in 1 BLISTER PACK; Type 0: Not a Combination Product	05/24/2011	06/30/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	05/04/2011	06/30/2017

Labeler - NCS HealthCare of KY, LLC dba Vangard Labs (050052943)

Name	Address	ID/FEI	Business Operations
Establishment
NCS HealthCare of KY, LLC dba Vangard Labs		050052943	repack(0615-4529)

Revised: 8/2021

Document Id: 415ed8df-7998-4f31-b38b-ad17e288e486

Set id: 078cbd93-be31-455a-802e-7869e39d363c

Version: 8

Effective Time: 20210831

NCS HealthCare of KY, LLC dba Vangard Labs