EX-LAX REGULAR STRENGTH CHOCOLATED STIMULANT LAXATIVE: Package Insert and Label Information

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 15-25o C (59-77o 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

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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

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