Gnp Fiber Therapy Tablet
FDA Label NDC 24385-466

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amerisource Bergen for the product Gnp Fiber Therapy (NDC 24385-466). 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 a doctor before use if you have, when using this product, stop use and ask a doctor if, keep out of reach of children, 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)

Methylcellulose 500 mg

Purpose

Bulk-forming laxative

Uses

  • helps restore and maintain regularity and relieves constipation (irregularity)
  • in the treatment of constipation associated with other bowel disorders when recommended by a doctor

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 A 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
  • sensitivity to any of the ingredients

When Using This Product

  • do not exceed recommended maximum dose unless directed by a doctor
  • do not use laxative products for a period longer than one week unless directed by a doctor

Stop Use And Ask A Doctor If

  • rectal bleeding occurs
  • you fail to have a bowel movement after use

Keep Out Of Reach Of Children

In case of overdose, get medical help or contact a poison control center right away.

Directions

This product generally produces effect in 12-72 hours

take this product (child or adult) dose with atleast 8 ounces (a full glass) of water or other fluid

taking this product without enough liquid may cause choking, see choking warning

 AGEDOSE MAXIMUM DOSE 
 adults and children over 12 years    2 caplets up to 6 times daily
 children (6 to 12 years) 1 caplet up to 6 times daily
 children under 6 years ask a doctor          ask a doctor                  

Other Information

  • each caplet contains: sodium 10 mg
  • store at room temperature 15o-30oC (59o-86oF)
  • protect contents from moisture
  • keep tightly closed
  • tamper evident: Do not use if printed seal under cap is torn or missing

Inactive Ingredients

citric acid, colloidal silicon dioxide, crospovidone, FD&C yellow 6 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium bicarbonate, sodium chloride, sodium lauryl sulphate

Principal Display Panel

Good Neighbor Pharmacy

compare to Citrucel caplets active ingredient

fiber therapy

Methylcellulose Fiber Laxativebulk-forming laxative

easy to take with you

gentle fiber for regularity

daily source of 100% soluble fiber

100 caplets

Box (Gnp188)

Box (Gnp188)

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