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Ex-lax maximum strength stimulant laxative - Medication Information

Product NDC Code 0067-8142
Drug Name

Ex-lax maximum strength stimulant laxative

Type Brand
Active Ingredients
Sennosides 25 mg/1
Route ORAL
Dosage Form PILL
RxCUI drug identifier 213073,
251292
Application Number M007
Labeler Name Haleon US Holdings LLC
Packages
Package NDC Code Description
0067-8142-01 2 blister pack in 1 carton (0067-8142-01) / 12 pill in 1 blister pack
0067-8142-02 4 blister pack in 1 carton (0067-8142-02) / 12 pill in 1 blister pack
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Sennosides 25 mg

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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
adults and children 12 years of age and older2 tablets once or twice daily
children 6 to under 12 years of age1 tablet once or twice daily
children under 6 years of ageask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
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

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses • relieves occasional constipation (irregularity) • generally produces bowel movement in 6 to 12 hours

Purpose

Information about the drug product’s indications for use.
Purpose Stimulant laxative

Spl product data elements

Usually a list of ingredients in a drug product.
EX-LAX MAXIMUM STRENGTH STIMULANT LAXATIVE SENNOSIDES SENNOSIDES SENNOSIDES ACACIA CALCIUM CARBONATE CARNAUBA WAX STARCH, CORN ANHYDROUS DIBASIC CALCIUM PHOSPHATE FD&C BLUE NO. 1 ALUMINUM OXIDE FERROSOFERRIC OXIDE MAGNESIUM STEARATE METHYLPARABEN MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 3350 POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE, UNSPECIFIED PROPYLENE GLYCOL PROPYLPARABEN SHELLAC SILICON DIOXIDE SODIUM BENZOATE SODIUM LAURYL SULFATE SUCROSE TALC TITANIUM DIOXIDE ex;lax;1

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
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

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Other information • each tablet contains : calcium 40 mg, magnesium 5 mg • store at controlled room temperature 20-25C (68-77F). 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

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
Ask Doctor before use if you have noticed a sudden change in bowel habits that persists over a period of 2 weeks

Ask doctor or pharmacist

Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.
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.

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do Not Use Do not use laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep Out of Reach of Children. In case of overdose, get medical help or contact a Poison Control Center right away.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or Comments? call 1-855-221-5432

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
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.

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When Using this product do not use for a period longer than 1 week

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast-feeding, ask a health professional before use.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings 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.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API