OTC Medication Information: EX-LAX REGULAR STRENGTH CHOCOLATED STIMULANT LAXATIVE

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.

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 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 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 10 mg

•

store at 15-25^o C (59-77^o F)

Inactive ingredients

cocoa powder, hydrogenated vegetable oils (palm kernel, palm), salt, soy lecithin, sugar, vanilla, whey powder (milk)

Questions or comments?

call 1-855-221-5432

Principal Display Panel

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

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-8140 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SENNOSIDES (SENNOSIDES) SENNOSIDES 15 mg

Inactive Ingredients Ingredient Name Strength COCOA HYDROGENATED PALM KERNEL OIL LECITHIN, SOYBEAN SUCROSE VANILLIN SODIUM CHLORIDE WHEY

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

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0067-8140-01 1 PACKAGE in 1 BOX contains a PACKAGE 1 12 TABLET, CHEWABLE in 1 PACKAGE This package is contained within the BOX (0067-8140-01) 2 NDC:0067-8140-02 2 PACKAGE in 1 BOX contains a PACKAGE 2 12 TABLET, CHEWABLE in 1 PACKAGE This package is contained within the BOX (0067-8140-02) 3 NDC:0067-8140-03 4 PACKAGE in 1 BOX contains a PACKAGE 3 12 TABLET, CHEWABLE in 1 PACKAGE This package is contained within the BOX (0067-8140-03)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 08/01/2017

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

Registrant — GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Establishment
Name	Address	ID/FEI	Operations
Alps Pharmaceutical Ind. Co., Ltd.		717077197	API MANUFACTURE (0067-8140)

Revised: 11/2020 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC