Laxacin
FDA Label NDC 68258-4985

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dispensing Solutions, Inc. for the product Laxacin (NDC 68258-4985). 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, purpose, uses, warnings, keep out of reach of children, directions, inactive ingredients, package/label principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Docusate Sodium 50 mg

Sennosides 8.6 mg

Purpose

Stool Softener

Laxative

Uses

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

Warnings

Do not use

  • if you are now taking mineral oil, unless directed by a doctor
  • laxative products for longer than 1 week unless directed by a doctor

    • 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

      • Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative.
      These may indicate 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.

LOT#

Exp. Date:

Directions

  • take preferably at bedtime or as directly by a doctor
    • agestarting dosemaximum dose
    adults and children 12 years and older2 tablets once a day4 tablets twice a day

    Other information

    • Each tablet contains: Calcium 20 mg
    • Each tablet contains: Sodium 4 mg
    • Store at room temperature
    • Keep lid tightly closed in a dry place
    • Do not use if imprinted safety seal under cap is broken or missing

Inactive Ingredients

Croscarmellose Sodium, D&C Yellow #10, Dextrose, Dicalcium Phosphate, FD&C Yellow #6, Hypromelose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Silica, Sodium Benzoate, Stearic Acid, Titanium Dioxide.

Questions? If you have any questions or comments, or to report an adverse event, please contact (480) 253-9761.

Manufactured for:
Alexso Inc.
Thousand Oaks, CA 91360

Package/Label Principal Display Panel

NDC 68258-4985-00

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