Premier Value Fiber Laxative
FDA Label NDC 68016-259

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Consortium for the product Premier Value Fiber Laxative (NDC 68016-259). 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, ask your doctor before use if you have, ask your doctor or pharmacist before use if, when using this product, stop use and ask a doctor if, 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 equivalent to 500 mg polycarbophil

Purpose

Bulk-forming laxative

Uses

  • relieves occasional constipation to help restore and maintain regularity
  • this product generally produces bowel movement in 12 to 72 hours.

Warnings

Choking: Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting or difficulty in swallowing or breathing after taking this product, seek immediate medical attention.

Ask Your Doctor Before Use If You Have

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

Ask Your Doctor Or Pharmacist Before Use If

you are taking any other drug. Take this product 2 or more hours before or after other drugs. All laxatives may affect how other drugs work.

When Using This Product

  • do not use for more than 7 days unless directed by a doctor
  • do not take more than 8 caplets in a 24 hour period unless directed by a doctor

Stop Use And Ask A Doctor If

rectal bleeding occurs or if you fail to have a bowel movement after use of this or any other laxative. These could be signs of a serious condition.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Directions

  • take each dose of this product with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning.
  • This product works naturally so continued use for one to three days is normally required to provide full benefit. Dosage may vary according to diet, exercise, previous laxative use or severity of constipation
    • agerecommended dosedaily maximumadults & children 12 years of age and over2 caplets once a dayup to 4 times a daychildren under 12 yearsconsult a physician
     
     
     
     
     
     
     
     

Other Information

  • each caplet contains: calcium 125 mg
  • do not use if printed seal under cap is torn or missing
  • store at 20-25°C (68-77°F)
  • protect contents from moisture

Inactive Ingredients

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

Principal Display Panel

NDC 68016-259-00

Premier Value

Fiber Caplets

FIBER LAXATIVE

Calcium Polycarbophil 625 mg

  • Relieves constipation
  • Restores regularity
  • Daily source of fiber

    • COMPARE TO FIBERCON® ACTIVE INGREDIENT

    90 CAPLETS

    This product is not manufactured or distributed by Pfizer Consumer Healthcare, the distributor of FIBERCON®

    Distributed by:

    Chain Drug Consortium LLC.

    3301 N.W. Boca Raton Blvd.

    Suite 101, Boca Raton FL 33431

    Fiber Laxative Label

    Premier Value Fiber Caplets 90ct (Image 01)

    Premier Value Fiber Caplets 90ct (Image 01)

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