Fiber Laxative
FDA Label NDC 49348-633

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 Laxative (NDC 49348-633). 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 capsule), purpose, otc - keep out of reach of children, uses, warnings, ask a doctor before use if you have, 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.

Active Ingredient (In Each Capsule)

Psyllium husk approx. 0.52 g

Purpose

Fiber laxative

Otc - Keep Out Of Reach Of Children


Uses

relieves:

  • occasional constipation
  • helps restore regularity
  • promotes normal function of the bowel

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
  • difficulty in swallowing
  • a sudden change in bowel habits that persists over a period of 2 weeks

When Using This Product

  • it may cause an allergic reaction in people sensitive to inhaled or ingested psyllium

Stop Use And Ask A Doctor If

  • you fail to have a bowel movement after use
  • rectal bleeding occurs
  • symptoms persist more than 1 week
  • Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately

Directions

  • take this product (child or adult dose) with a full glass of water (8oz.) or other fluid. Taking this product without enough liquid may cause choking. See choking warning.
  • swallow capsules one at a time
  • daily maximum 3 doses
  • dosage will vary according to diet, exercise, previous laxative use or severity of constipation.
  • product generally produces effect in 12-72 hours.
  • adults and children 12 years and older5 capsules, 1 to 3 times a day
    children 6 to under 11 yearsconsider use of powder form of product
    children under 6 yearsask a doctor
    • Laxatives, including bulk fibers, may affect how well other medicines work. If you are taking a prescription medicine by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine. As your body adjusts to increased fiber intake, you may experience changes in bowel habits or minor bloating.

Other Information

  • do not use if printed seal under cap is torn or missing.
  • store at room temperature
  • protect contents from moisture.

Inactive Ingredients

caramel color, gelatin, iron oxide, polysorbate 80, shellac

Fiber Supplement Information

Uses: An easy way to increase your daily fiber intake. Diets low in saturated fat and cholesterol that include 7 grams of soluble fiber per day from psyllium husk, as in this product, may reduce the risk of heart disease by lowering  cholesterol. One serving of this product provides 2.4 grams of this soluble  fiber. consult a doctor if you are considering use of this product as part of a cholesterol lowering program.

Warnings: Read entire label, including warnings in Drug Facts

Directions: Adults 12 years and older: 2-6 capsules for increasing daily fiber intake;  6 capsules for cholesterol lowering use. Take this product 8oz. of liquid (swallow 1 capsule at a  time)  up to 3 times daily.  NOTICE:  Take this product atleast  8 oz . (a full glass) of liquid. Taking this product without enough liquid may cause choking.  Do not take if you have difficulty swallowing.

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fiber laxative

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