SENNA LAXATIVE- sennosides tablet, coated
PLD Acquisitions LLC DBA Avéma Pharma Solutions

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 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 using 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
you fail to have a bowel movement after use

These may indicate a serious condition.

If pregnant or breast-feeding

If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children

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	2 tablets once a day	4 tablets twice a day
children 6 to under 12 years of age	1 tablet once a day	2 tablets twice a day
children 2 to under 6 years of age	1/2 tablet once a day	1 tablet twice a day
children under 2 years of age	ask a doctor	ask a doctor

Other information

each tablet contains: calcium 25 mg/tablet
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
do not use if imprinted safety seal under cap is broken or missing
*This product is not manufactured or distributed by Purdue Pharma L.P., owner of the registered trademark Senokot®.

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, *dicalcium phosphate anhydrous, hypromellose, maltodextrin, magnesium stearate, microcrystalline cellulose, *mineral oil, *polyethylene glycol, stearic acid, talc, triacetin. *May also contain.

Package/Label Principal Display Panel

NDC 63548-4000-*1

GENTLE RELIEF

Senna Laxative

SENNOSIDES USP, 8.6 mg EACH

·Natural Vegetable Laxative Ingredient

100 TABLETS

Do not use if imprinted safety seal under cap is broken or missing

SENNA LAXATIVE
sennosides tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63548-1278
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	8.6 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BROWN	Score	no score
Shape	ROUND	Size	4mm
Flavor		Imprint Code	S3
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63548-1278-1	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/02/2010	02/28/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part334	01/02/2010	02/28/2017

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

Revised: 3/2017

Document Id: 893191c3-950c-4239-acb0-09e97a2357da

Set id: dccb0b89-87d9-4a27-8b3b-39e8c84e3a3e

Version: 2

Effective Time: 20170331

PLD Acquisitions LLC DBA Avéma Pharma Solutions