Ex-lax Pill
FDA Label NDC 0067-8142

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Ex-lax (NDC 0067-8142). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, do not use, ask doctor before use if you have, ask a doctor or pharmacist before use if you, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Sennosides, 25 mg

Purpose

Stimulant laxative

Uses

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

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

  • swallow tablet with a glass of water
  • swallow tablet 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

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

Inactive Ingredients

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

Questions?

call 1-855-221-5432

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 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.

Distributed by: GlaxoSmithKline Consumer Healthcare Holdings (US), LLC. Warren, NJ 07059 ©20xx

Package/Label Principal Display Panel

NDC 0067-8142-01

Maximum Strength

ex•lax®

SENNOSIDES, USP, 25 mg

STIMULANT LAXATIVE

RELIEF GUARANTEED

GENTLE OVERNIGHT RELIEF YOU CAN TRUST

13142 Exlax- 24 Ct.jpg (800366b2 E974 4791 9a0d C341c80ac859 01)

13142 Exlax- 24 Ct.jpg (800366b2 E974 4791 9a0d C341c80ac859 01)

* Please review the disclaimer below.