SENNA NATURAL VEGETABLE LAXATIVE- sennosides tablet

Senna by

Drug Labeling and Warnings

Senna by is a Otc medication manufactured, distributed, or labeled by Best Choice (Valu Merchandisers Company), P & L Development, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 using if you have

• stomach pain
• nausea
• vomiting
• noticed a sudden change in bowel habits 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	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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive ingredients

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

*contains one or more of these ingredients

Questions or comments?

Call toll free: 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENT IN SENOKOT®†

Senna

NATURAL VEGETABLE LAXATIVE INGREDIENT

SENNOSIDES 8.6 mg

For relief of constipation

TABLETS

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

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Product Labeling

Sennosides 8.6 mg

INGREDIENTS AND APPEARANCE

SENNA  NATURAL VEGETABLE LAXATIVE
sennosides tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63941-486
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)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)

Product Characteristics
Color	BROWN	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	0813;AV;S8;TCL080
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63941-486-01	1 in 1 BOX	12/16/2015	12/31/2020
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	12/16/2015	12/31/2020

Labeler - Best Choice (Valu Merchandisers Company) (868703513)

Registrant - P & L Development, LLC (079765031)