Soluble Fiber Tablet
FDA Label NDC 41163-288

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by United Natural Foods, Inc. Dba Unfi for the product Soluble Fiber (NDC 41163-288). 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, use(s), warnings, ask a doctor before use if you have, when using this product, stop use and ask 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

Use(S)

  • relieves occasional constipation to help restore and maintain regularity
  • generally produces a bowel movement in 12-72 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 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

When Using This Product

  • do not use laxative products for a period longer than one week unless directed by a doctor.
  • do not use if you are on a low salt diet unless directed by a doctor.

Stop Use And Ask Doctor If

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

    • 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

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.

    •  AGE DOSEMAXIMUM DOSE 
     adults & children 12 years & over 2 caplets up to 6 times daily
     children 6 to 11 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 below 25oC (77oF)
  • protect contents from moisture
  • keep tightly closed

Inactive Ingredients

citric acid, colloidal silicon dioxide, crospovidone, FD&C yellow no.6 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium bicarbonate, sodium chloride, sodium lauryl sulfate.

Principal Display Panel

NDC 41163-288-16
Compare to Citrucel Caplets active ingredient*
EQUALINE
soluble fiber caplets
methylcellulose 500 mg
bulk forming laxative


  • gently relieves constipation

    • 100 Caplets



    188 (188)

    188 (188)



* Please review the disclaimer below.