EX-LAX MAXIMUM STRENGTH STIMULANT LAXATIVE- sennosides pill 
Novartis Consumer Health, Inc.

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.

----------

Drug Facts

Active ingredient

Sennosides, USP, 25 mg

Purpose

Stimulant laxative

Uses

Warnings

Do Not Use

Do not use laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor

Ask 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 any other 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 right away.

Directions

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

Inactive ingredients

acacia, alginic acid, carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate, FD&C blue no.1 aluminum lake, iron oxide black, magnesium stearate, microcrystalline cellulose, potassium hydroxide, povidone, pregelatinized starch, propylene glycol, shellac, sodium benzoate, sodium lauryl sulfate, stearic acid, sucrose, talc, titanium dioxide

Questions?

call 1-800-452-0051

Additional information listed on other panels

The Ex•Lax® Guarantee: When taken as directed, Ex•Lax® is guaranteed to work gently and effectively overnight or your money back. Return product to Novartis, attention Consumer Affairs, for full refund.

Tamper Evident Feature: Ex•Lax® Pills are sealed in blister packets. Use only if the individual seal is unbroken.

Distributed by: Novartis Consumer Health, Inc. Parsippany, NJ 07054-0622 ©20xx

Package/Label Principal Display Panel

NDC 0067-0016-24

Maximum Strength

ex•lax®

SENNOSIDES, USP, 25 mg

STIMULANT LAXATIVE

RELIEF GUARANTEED EVERY TIME

GENTLE OVERNIGHT RELIEF YOU CAN TRUST

Ex-Lax MS Pills 24 ct Carton
EX-LAX  MAXIMUM STRENGTH STIMULANT LAXATIVE
sennosides pill
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-0016
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES 25 mg
Inactive Ingredients
Ingredient Name Strength
ACACIA (UNII: 5C5403N26O)  
ALGINIC ACID (UNII: 8C3Z4148WZ)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color BLUE Score no score
Shape ROUND Size 11mm
Flavor Imprint Code ex;lax;1
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0067-0016-24 2 in 1 CARTON
1 12 in 1 BLISTER PACK
2 NDC:0067-0016-90 6 in 1 CARTON
2 15 in 1 BLISTER PACK
3 NDC:0067-0016-48 4 in 1 CARTON
3 12 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 01/01/2012
Labeler - Novartis Consumer Health, Inc. (879821635)

Revised: 2/2013
Document Id: 800366b2-e974-4791-9a0d-c341c80ac859
Set id: 800366b2-e974-4791-9a0d-c341c80ac859
Version: 1
Effective Time: 20130201
 
Novartis Consumer Health, Inc.