Fiber Original Texture
FDA Label NDC 49348-166

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mckesson for the product Fiber Original Texture (NDC 49348-166). 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 (per each rounded teaspoon=7 g), purpose, otc - keep out of reach of children, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (Per Each Rounded Teaspoon=7 G)

Psyllium husk 3.4 g

Purpose

Bulk-forming laxative

Otc - Keep Out Of Reach Of Children


Uses

  • effective in treating occasional constipation and restoring regularity

Warnings

Allergy alert: May cause allergic reaction in people sensitive to ingested or inhaled psyllium

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 persisting for 2 weeks

Ask A Doctor Or Pharmacist Before Use If You Are

taking any other drug. Laxatives may affect how other drugs work.

When Using This Product

  • do not exceed the maximum recommended daily dosage in a 24-hour period
  • you may experience changes in bowel habits or minor bloating as your body adjusts to increased fiber intake

Stop Use And Ask A Doctor If

  • constipation lasts more than 7 days
  • rectal bleeding occurs
    • 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

  • take at the first sign of irregularity up to 3 times a day
  • put one dose into an empty glass
  • fill glass with 8oz of water or favorite beverage
  • stir briskly and drink promptly
  • if mixture thickens add more water and stir
  • take this product (child or adult dose) 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.
  • if you are taking a prescription medicine by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine.
    • New Users: Start with 1 dose per day; gradually increase to 3 doses per day as necessary

    adults and children 12 years and over
    		1 rounded teaspoon                          
    6 to under 12 years
    		1/2 teaspoon
    under 6 years
    		ask a doctor

Other Information

  • each teaspoon contains: potassium 30 mg and sodium 3 mg
  • store at (20o-25oC) 68o-77oF

Inactive Ingredients

silicon dioxide, sucrose

DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR BROKEN

Fiber Supplement Information

Uses Diets low in saturated fat and cholesterol that include 7 grams of soluble fiber per day from psyllium seed husk, may reduce the risk of heart disease by lowering cholesterol levels. One ADULT serving provides 2.4 grams of soluble fiber. Consult a doctor if you are considering use of the products as part of a cholesterol-lowering program.

Warnings Read entire label, including warnings in Drug Facts

Directions Adults 12 years and older: 1 rounded TEASPOON (tsp) in 8 oz  of liquid 3 times daily.

Children under 12 years:  Consult a doctor.

NOTICE: Mix this product with at least 8 ounces (a full glass) of liquid. Taking this product without enough liquid may cause choking. Do not take  if you have difficulty swallowing.  See choking warning.

Pdp

Sunmark

compare to the active ingredient in Metamucil®

Fiber Original Texture

psyllium husk 3.4 g

Bulk-forming laxative

Dietary fiber supplement

100% NATURAL PSYLLIUM HUSK POWDER

REGULAR FLAVOR

48 Teaspoon doses

NET WT 13 oz (368 g)

FILL CONTROLLED BY WEIGHT, NOT VOLUME

Unflavored Original Texture (Sm401)

Unflavored Original Texture (Sm401)

* Please review the disclaimer below.