Senna Laxative by Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) / P & L Development, LLC DRUG FACTS

Senna Laxative by

Drug Labeling and Warnings

Senna Laxative by is a Otc medication manufactured, distributed, or labeled by Dolgencorp, Inc. (DOLLAR GENERAL & REXALL), P & L Development, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SENNA LAXATIVE NATURAL VEGETABLE LAXATIVE- sennosides tablet 
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)

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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DRUG FACTS

Active Ingredient (in each tablet)

Sennosides 8.6 mg

Purpose

Laxative

Uses

• relieves occasional constipation (irregularity)
  
• generally produces a 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 over 12 years of age or older	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 25 mg
  
• store at 25o C (77o F); excursions permitted between 15o - 30o C (59o- 86o F)

Inactive Ingredients

croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, liquid paraffin*, magnesium stearate, maltodextrin*, microcrystalline cellulose, mineral oil*, silicon dioxide*, stearic acid*, sodium lauryl sulfate*, talc*, triacetin*

*contains one or more of these ingredients

Questions or comments?

Call toll free: 1-888-309-9030

Principal Display Panel

Compare to active ingredient in senokot® **

Senna Laxative

Sennosides 8.6 mg

Standardized senna concentrate

Natural vegetable laxative ingredient

**This product is not manufactured or distributed by Purdue Pharma L.P., owner of the registered trademark Senokot®

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Product Label

Sennosides 8.6 mg

SENNA LAXATIVE  NATURAL VEGETABLE LAXATIVE
sennosides tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-181
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TRIACETIN (UNII: XHX3C3X673)
MINERAL OIL (UNII: T5L8T28FGP)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Product Characteristics
Color	BROWN	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	S3;TCL080;S8
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-181-01	1 in 1 BOX	07/07/2010	01/01/2020
1		100 in 1 BOTTLE; 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	07/07/2010	01/01/2020

Labeler - Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) (068331990)

Registrant - P & L Development, LLC (800014821)

Revised: 12/2012

Document Id: 8539d654-74e4-42ac-baef-e71abcb26ed8

34390-5

Set id: 8b35f532-48f5-4854-a6dc-606f52261f0d

Version: 3

Effective Time: 20121218

 

Dolgenc