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Laxative maximum strength - Medication Information

Product NDC Code 55301-348
Drug Name

Laxative maximum strength

Type Brand
Active Ingredients
Sennosides 25 mg/1
Route ORAL
Dosage Form TABLET, SUGAR COATED
RxCUI drug identifier 251292
Application Number 505G(a)(3)
Labeler Name ARMY AND AIR FORCE EXCHANGE SERVICE
Packages
Package NDC Code Description
55301-348-08 2 blister pack in 1 carton (55301-348-08) / 12 tablet, sugar coated in 1 blister pack
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient (in each tablet) Sennosides USP, 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(s) with a glass of water swallow tablet(s) whole; do not crush, break, or chew adults and children 12 years and over 2 tablets once or twice daily children 6 to under 12 years 1 tablet once or twice daily children under 6 years ask a doctor
adults and children 12 years and over2 tablets once or twice daily
children 6 to under 12 years1 tablet once or twice daily
children under 6 yearsask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients acacia, calcium carbonate, carnauba wax, corn starch, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, iron oxide black, magnesium stearate, methylparaben, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, propylparaben, shellac glaze, 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.
Laxative Maximum Strength Sennosides SENNOSIDES SENNOSIDES ACACIA CALCIUM CARBONATE CARNAUBA WAX STARCH, CORN DIBASIC CALCIUM PHOSPHATE DIHYDRATE FD&C BLUE NO. 1 ALUMINUM LAKE FERROSOFERRIC OXIDE MAGNESIUM STEARATE METHYLPARABEN MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE, UNSPECIFIED PROPYLENE GLYCOL PROPYLPARABEN SHELLAC SILICON DIOXIDE SODIUM BENZOATE SODIUM LAURYL SULFATE SUCROSE TALC TITANIUM DIOXIDE 44;348

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 Compare To The Active Ingredient of ex•lax ® Maximum Strength* exchange ✔ select ™ MAXIMUM STRENGTH laxative sennosides USP, 25 mg stimulant laxative Actual Size 24 Tablets GENTLE, DEPENDABLE OVERNIGHT RELIEF ✔ quality value TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING "SATISFACTION GUARANTEED OR YOUR MONEY BACK" Manufactured For Your Military Exchanges Distributed by: LNK International, Inc. Hauppauge, NY 11788 1-800-426-9391 *This product is not manufactured or distributed by GSK Consumer Healthcare S.A., owner of the registered trademark ex•lax ® Maximum Strength. 50844 REV0419B34808 Exchange Select 44-348 Exchange Select 44-348

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 a 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 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 (1-800-222-1222) 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? 1-800-426-9391

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.

Storage and handling

Information about safe storage and handling of the drug product.
Other information each tablet contains: calcium 40 mg, magnesium 5 mg TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number

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 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 (1-800-222-1222) 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