Leader Fiber
FDA Label NDC 53808-0963

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by State Of Florida Doh Central Pharmacy for the product Leader Fiber (NDC 53808-0963). 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 (in each caplet), purpose, uses, warnings, stop use and ask a doctor if, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Caplet)

Calcium polycarbophil 625 mg

Purpose

Bulk-forming laxative

Uses

relieves:

  • constipation
  • helps restore & maintain regularity
  • promotes normal function of the bowel

Warnings

Do not use if

  • you have abdominal pain, nausea or vomiting
  • you have difficulty in swallowing
  • you have noticed a sudden change in bowel habits that persists over a period of 2 weeks

    • Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking.

Stop Use And Ask A Doctor If

  • you experience chest pain, abdominal pain, nausea, vomiting, difficulty in breathing or swallowing
  • you fail to have a bowel movement after use
  • rectal bleeding occurs
  • symptoms persist more than 1 week

    • Drug interaction precaution: Contains calcium. If you are taking any form of tetracycline antibiotic, this product should be taken 1 hour before or 2 hours after you have taken the antibiotic

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • take this product (child or adult dose) with a full glass of water (8oz)
  • daily maximum 4 doses
  • dosage may vary according to diet, exercise, previous laxative use or severity of constipation
  • continued use for 1 to 3 days is normally required to provide full benefit
  • adults and children 12 years of age and over2 caplets once a dayup to 4 times a day
    children under 12 yearsconsult a physician

Other Information

  • each caplet contains: calcium 122 mg
  • do not use if printed seal under cap is torn or missing
  • store at room temperature
  • protect contents from moisture

Inactive Ingredients

calcium carbonate, caramel, crospovidone, hypromellose, maltodextrin, microcrystalline cellulose, magnesium stearate, methylcellulose, polyethylene glycol, silicon dioxide, sodium lauryl sulfate

Package Label

Distributed By:

Cardinal Health

Dublin Ohio 43017

www.myleader.com

This Product was Repackaged By:

State of Florida DOH Central Pharmacy
104-2 Hamilton Park Drive
Tallahassee, FL 32304
USA

Label Image for 53808-0963
625mg

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