Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

EX-LAX REGULAR STRENGTH CHOCOLATED STIMULANT LAXATIVE- sennosides tablet, chewable 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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

Sennosides, 15 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 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:

  chew 2 chocolated pieces once or twice daily

• children 6 to under 12 years of age:

  chew 1 chocolated piece once or twice daily

• children under 6 years of age:

  ask a doctor

Other information

• each piece contains: potassium 10mg
• sodium free
• store at controlled room temperature 20-25o C (68-77o F)

Inactive ingredients

cocoa, confectioners’ sugar, hydrogenated palm kernel oil, lecithin, non-fat dry milk, vanillin

Questions?

call 1-800-452-0051

Principal Display Panel

EX-LAX  REGULAR STRENGTH CHOCOLATED STIMULANT LAXATIVE
sennosides tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0067-0005
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	15 mg

Inactive Ingredients
Ingredient Name	Strength
COCOA (UNII: D9108TZ9KG)
SKIM MILK (UNII: 6A001Y4M5A)
HYDROGENATED PALM OIL (UNII: 257THB963H)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SUCROSE (UNII: C151H8M554)
VANILLIN (UNII: CHI530446X)

Product Characteristics
Color	BROWN	Score	no score
Shape	RECTANGLE	Size	68mm
Flavor	CHOCOLATE	Imprint Code	ex;lax
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0067-0005-24	2 in 1 BOX	01/01/2010	10/31/2019
1		12 in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC: 0067-0005-48	4 in 1 BOX	01/01/2010	10/31/2019
2		12 in 1 PACKAGE; Type 0: Not a Combination Product
3	NDC: 0067-0005-12	1 in 1 BOX	01/01/2010	10/31/2019
3		12 in 1 PACKAGE; 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	01/01/2010	10/31/2019

Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 5/2018

Document Id: 0c6e02d4-69e5-471a-a44c-ecc154389f6c

34390-5

Set id: eaec61d6-21e4-4e9f-b241-b0059302e926

Version: 3

Effective Time: 20180508

 

GlaxoSmithKli