FDA Label for Ex-lax Maximum Strength Stimulant Laxative

View Indications, Usage & Precautions

Ex-lax Maximum Strength Stimulant Laxative Product Label

The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


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