FDA.reportPublic FDA data

EX-LAX

Manufacturer
Haleon US Holdings LLC
Effective date
2024-12-17
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:44:23

Label at a glance#

ProductEX-LAX MAXIMUM STRENGTH STIMULANT LAXATIVE
Active ingredientSENNOSIDES
Label structure10 sections

Indications and uses

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

Dosage and administration

• swallow tablet(s) with a glass of water • swallow tablet(s) whole, do not crush, break or chew adults and children 12 years of age and older 2 tablets once or twice daily children 6 to under 12 years of age 1 tablet once or twice daily children under 6 years of age ask a doctor

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Sennosides 25 mg

Purpose

OTC - PURPOSE SECTION

Stimulant laxative

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do Not Use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

do not use for a period longer than 1 week

Stop use and ask a doctor if

OTC - STOP USE SECTION

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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep Out of Reach of Children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • swallow tablet(s) with a glass of water
  • swallow tablet(s) whole, do not crush, break or chew

adults and children 12 years of age and older

2 tablets once or twice daily

children 6 to under 12 years of age

1 tablet once or twice daily

children under 6 years of age

ask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • each tablet contains: calcium 40 mg, magnesium 5 mg
  • store at controlled room temperature 20-25C (68-77F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

acacia, calcium carbonate, carnauba wax, corn starch dibasic calcium phosphate, FD&C blue no.1 aluminum lake, iron oxide black, magnesium stearate, methyl paraben, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, propylparaben, shellac, silicon dioxide, sodium benzoate, sodium lauryl sulfate, sucrose, talc, titanium dioxide

Questions or Comments?

OTC - QUESTIONS SECTION

call 1-855-221-5432

Additional information listed on other panels

SPL UNCLASSIFIED SECTION

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 GSK, attention Consumer Affairs, for full refund.

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH

ex•lax

SENNOSIDES, 25 mg

STIMULANT LAXATIVE

RELIEF GUARANTEED

24 TABLETS

GENTLE OVERNIGHT RELIEF YOU CAN TRUST

Ex-Lax Max Strength 24 Tabs
Ex-Lax Max Strength 24 Tabs

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
213073Ex-Lax Maximum Strength 25 MG Oral TabletPSN6
251292sennosides 25 MG Oral TabletPSN6
213073sennosides, USP 25 MG Oral Tablet [Ex-Lax Maximum Relief Formula]SBD6
251292sennosides, USP 25 MG Oral TabletSCD6
213073Ex-Lax Maximum Relief Formula 25 MG Oral TabletSY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-8142-01EX-LAXMAXIMUM STRENGTH STIMULANT LAXATIVE12 in 1 BLISTER PACKPILL126
0067-8142-01EX-LAXMAXIMUM STRENGTH STIMULANT LAXATIVE2 in 1 CARTONPILL26
0067-8142-02EX-LAXMAXIMUM STRENGTH STIMULANT LAXATIVE12 in 1 BLISTER PACKPILL126
0067-8142-02EX-LAXMAXIMUM STRENGTH STIMULANT LAXATIVE4 in 1 CARTONPILL46

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-8142EX-LAX MAXIMUM STRENGTH STIMULANT LAXATIVE (SENNOSIDES) PILL [HALEON US HOLDINGS LLC]6Current NDC, Legacy NDC, 4 package rows20241219_fb170340-c996-46cf-b165-84e136ba4151.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0067-8142-01EA - Each0067-8142ff3c59f3-197f-4ec3-af8b-e9e43ff9918e12022-10-06
0067-8142-02EA - Each0067-8142f206bb4d-db09-42d0-83ff-549032b29f6e12024-11-05

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0067-81420067-8142-01, 0067-8142-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
SENNOSIDES3FYP5M0IJXACTIB
ACACIA5C5403N26OIACT
CALCIUM CARBONATEH0G9379FGKIACT
CARNAUBA WAXR12CBM0EIZIACT
STARCH, CORNO8232NY3SJIACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
ALUMINUM OXIDELMI26O6933IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
MAGNESIUM STEARATE70097M6I30IACT
METHYLPARABENA2I8C7HI9TIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL 3350G2M7P15E5PIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
SHELLAC46N107B71OIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SUCROSEC151H8M554IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EX-LAX MAXIMUM STRENGTH STIMULANT LAXATIVESENNOSIDESHaleon US Holdings LLCfb170340-c996-46cf-b165-84e136ba41512024-12-17WarningsExact identifier
ndc (package): 0067-8142-02
ndc (package): 0067-8142-01
ndc (product): 0067-8142
ndc11 (package): 00067814201
ndc11 (package): 00067814202
spl id: 2133e636-8bf8-4e31-b653-1ea9dc773e7e
spl set id: fb170340-c996-46cf-b165-84e136ba4151

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.