RxNorm Names

Review RxNorm Normal Forms

MAXIMUM STRENGTH LAXATIVE (sennosides) tablet
[WALGREEN CO.]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3b4b98fe-0067-4d4e-afc1-fd32e8388ef7

Category	DEA Schedule	Marketing Status
HUMAN OTC DRUG LABEL		OTC monograph not final

NOTE: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.

Drug Label Sections

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

Active ingredient (in each pill)

Sennosides USP, 25 mg

Purpose

Stimulant laxative

Uses

relieves occasional constipation (irregularity)
generally produces bowel movement in 6 to 12 hours

Warnings

Do not use

laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor

Ask a doctor before use if you have

noticed a sudden change in bowel habits that persists over a period of 2 weeks

Ask a doctor or pharmacist before use if you

are taking a presciption drug. Laxatives may affect how other drugs work. Take this product 2 or more hours before or after other drugs

When using this product

do not use for a period longer than 1 week

Stop use and ask a doctor if

rectal bleeding or failure to have a bowel movement occur after use of a laxative. These may be signs of 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 immediately.

Directions

Swallow pill(s) with a glass of water
Swallow pill(s) whole, do not crush, break or chew

adults and children 12 years of age and older	2 pills once or twice daily
children 6 to under 12 years of age	1 pill once or twice daily
children under 6 years of age	ask a doctor

Other information

each pill contains: calcium 20 mg
store at controlled room temperature 15º to 30ºC (59º-86ºF)
see end flag for expiration date and lot number
for better identification keep pills in carton until used

Inactive ingredients

acacia, calcium carbonate, carnauba wax, corn starch, dicalcium phosphate, FD&C blue #1 aluminum lake, iron oxide black, magnesium stearate, maltodextrin*, methylparaben, microcrystalline cellulose, polyethylene glyocol, polyvinyl lacohol, povidone, propylene glycol, propylparaben, shellac, silica gel, sodium benzoate, sodium lauryl sulfate, sucrose, talc, titanium dioxide

*may also contain this ingredient

Questions or Comments?

1-888-309-9030

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Well at Walgreens

NDC 0363-0348-08

WALGREENS PHARMACIST RECOMMENDEDǂ

MAXIMUM STRENGTH
Laxative
Pills
Sennosides USP, 25 mg
• Gentle, dependable overnight relief

24 PILLS

Compare to ex•lax® Maximum Strength active ingredientǂǂ

ǂWalgreens Pharmacist Survey Study, November 2010

ǂǂThis product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark ex•lax® Maximum Strength.
50844 ORG041034808

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Walgreens 44-348

MAXIMUM STRENGTH LAXATIVE
sennosides tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0348
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SENNOSIDES A AND B (SENNOSIDES A AND B)	SENNOSIDES A AND B	25 mg

Inactive Ingredients
Ingredient Name	Strength
ACACIA
CALCIUM CARBONATE
CARNAUBA WAX
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
FD&C BLUE NO. 1
MAGNESIUM STEARATE
MALTODEXTRIN
METHYLPARABEN
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
POLYVINYL ALCOHOL
PROPYLENE GLYCOL
PROPYLPARABEN
SHELLAC
SODIUM BENZOATE
SODIUM LAURYL SULFATE
SUCROSE
TALC
TITANIUM DIOXIDE

Product Characteristics
Color	BLUE	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	44;348
Contains

Packaging
#	Item Code	Package Description
1	NDC:0363-0348-08	2 in 1 CARTON
1		12 in 1 BLISTER PACK
2	NDC:0363-0348-22	4 in 1 CARTON
2		12 in 1 BLISTER PACK
3	NDC:0363-0348-52	90 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	01/04/2003

Labeler - WALGREEN CO. (008965063)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(0363-0348)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(0363-0348)

Revised: 12/2012

Document Id: 2ed880b3-d351-414e-9de9-88ff60a2756f

Set id: 3b4b98fe-0067-4d4e-afc1-fd32e8388ef7

Version: 2

Effective Time: 20121201

WALGREEN CO.

Daily Med

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