SENNA LAXATIVE- sennosides tablet

Senna laxative by

Drug Labeling and Warnings

Senna laxative by is a Otc medication manufactured, distributed, or labeled by PLD Acquisitions LLC DBA Avéma Pharma Solutions. 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 within 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 25o C (77o F); excursions permitted between 15_30oC (59_86oF)

Inactive Ingredients

croscarmellose sodium, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol*, polyvinyl alcohol, silicon dioxide*, stearic acid*, talc

Questions or comments?

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

Principal Display Panel

†Compare to the active ingredient in Senokot®

Natural Laxative

Sennosides, 8.6 mg

Laxative

Natural Vegetable laxative ingredient

gentle, overnight relief

Tablets

†This product is not manufactured or distributed by Purdue Products L.P., distributor of Senokot®.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

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

Manufactured by:

Avema Pharma Solutions

10400 NW 29th Terrace

Miami, FL 33172

Product Label

Natural Laxative Sennosides Brown Tablet

INGREDIENTS AND APPEARANCE

SENNA LAXATIVE 
sennosides tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63548-0486
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)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
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
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63548-0486-1	1000 in 1 BOTTLE; Type 0: Not a Combination Product	01/02/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	01/02/2010

Labeler - PLD Acquisitions LLC DBA Avéma Pharma Solutions (804087794)