Active Ingredient (In Each Tablet)
Sennosides 15 mg
Ex-lax
FDA Label NDC 0067-0003
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 0067-0003). 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 (in each tablet), purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, 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.
Label Section Quick Index
Purpose
Stimulant laxative
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 6 to 12 hours
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
- 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
- each tablet contains: calcium 45 mg, magnesium 5mg
- store at controlled room temperature 20-25°C (68-77°F)
Inactive Ingredients (0067-0003)
acacia, alginic acid, carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate, iron oxides, magnesium stearate, microcrystalline cellulose, potassium hydroxide, pregelatinized starch, propylene glycol, shellac, sodium benzoate, sodium lauryl sulfate, stearic acid, sucrose, talc, titanium dioxide
Inactive Ingredients (0067-8141)
acacia, calcium carbonate, carnauba wax, corn starch, dibasic calcium phosphate, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, methylparaben, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, propylparaben, shellac, silicon dioxide, sodium benzoate, sodium lauryl sulfate, sucrose, talc, titanium dioxide
Questions ?
call 1-855-221-5432
Principal Display Panel
NDC 0067-0003-30
Regular Strength
ex•lax®
SENNOSIDES, USP, 15 mg
STIMULANT LAXATIVE
RELIEF GUARANTEED EVERY TIME
GENTLE OVERNIGHT RELIEF YOU CAN TRUST
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 Novartis, attention Consumer Affairs, for full refund.
Tamper Evident Feature: Ex•Lax® Pills are sealed in blister packets. Use only if the individual seal is unbroken.
Trademarks are owned by or licensed to GSK group of companies
Distributed by: Novartis Consuemr Health, Inc.
Parsippany, NJ 07054-0622
Ex-lax Rs Pills Pdp (62544c2f 6e30 4cec Ae63 233715ef0699 01)
NDC 0067-8141-02
ex•lax®
SENNOSIDES, 15 mg
REGULAR STRENGTH
STIMULANT LAXATIVE
RELIEF GUARANTEED
GENTLE OVERNIGHT RELIEF YOU CAN TRUST
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.
Trademarks are owned by or licensed to the GSK group of companies.
Distributed by:
GSK Consumer Healthcare
Warren, NJ 07059
©2017 GSK or its licensor. All rights reserved
13143
* Please review the disclaimer below.
