Exchange Select Tablet
FDA Label NDC 55301-107

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Army And Air Force Exchange Service for the product Exchange Select (NDC 55301-107). 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 otc - active ingredient, purpose, indications & usage, warnings, otc - do not use, otc - ask doctor/pharmacist, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Drug Facts

Active ingredient (in each tablet)

Sennosides 8.6 mg

Purpose

Laxative

Indications & Usage

Uses

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

Warnings

Warnings

Otc - Do Not Use

Do not use

  • laxative products for longer than 1 week unless directed by a doctor

Otc - Ask Doctor/Pharmacist

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that continues over a period of 2 weeks

Otc - Stop Use

Stop use and ask a doctor ifyou have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-22-1222.

Dosage & Administration

Directions

  • take preferably at bedtime or as directed by a doctor
  • age

    starting dosage

    maximum dosage

    adults and children
    12 years of age and over

    2 tablets once a day

    4 tablets twice a day

    children 6 to under 12 years

    1 tablet once a day

    2 tablets twice a day

    children 2 to under 6 years

    1/2 tablet once a day

    1 tablet twice a day

    children under 2 years

    ask a doctor

    ask a doctor

Other

Other Information

  • store at room temperature

Inactive Ingredient

Inactive ingredients

microcrystalline cellulose, magnesium stearate, starch

Questions Or Comments?

1-866-467-2748

Tamper Evident: Do Not Use If Printed Seal Under Cap Is Broken Or Missing

IMPORTANT: Keep this carton for future reference on full labeling.

*This product is not manufactured or distributed by Avrio Health L.P., owner of the registered trademark Senokot®

SATISFACTION GUARANTEED OR YOUR MONEY BACK”

Manufactured For Your Military Exchanges By: Raritan Pharmaceuticals Inc., 8 Joanna Court, East Brunswick, NJ 08816

Package Label.Principal Display Panel

*Compare to the active ingredient of Senokot®

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NDC 55301-107-00

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