Metamucil Powder
FDA Label NDC 37000-023

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Procter & Gamble Manufacturing Company for the product Metamucil (NDC 37000-023). 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 other, active ingredient (in each tablespoon), purpose, uses, choking, allergy alert, otc - ask doctor, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Dist. by Procter & Gamble, Cincinnati OH 45202

Active Ingredient (In Each Tablespoon)

Psyllium husk approximately 3.4 g

Purpose

Fiber therapy for regularity

Uses

  • effective in treating occasional constipation and restoring regularity

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.

Allergy Alert

This product may cause allergic reaction in people sensitive to inhaled or ingested psyllium.

Otc - Ask Doctor

Ask a doctor before use if you have

  • a sudden change in bowel habits persisting for 2 weeks
  • abdominal pain, nausea or vomiting

Otc - Stop Use

Stop use and ask a doctor if

  • constipation lasts more than 7 days
  • rectal bleeding occurs

    • These may be signs of a serious condition.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, contact a doctor or a Poison Control Center right away.

Directions

Put one dose into an empty glass. Mix 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. Stir briskly and drink promptly. If mixture thickens, add more liquid and stir.

Adults 12 yrs. & older1 rounded TABLESPOON in 8 oz of liquid at the first sign of irregularity. Can be taken up to 3 times daily. Generally produces effect in 12 – 72 hours.
6 – 11 yrs.½ adult dose in 8 oz of liquid, up to 3 times daily
Under 6 yrs.Consult a doctor

Bulk-forming fibers like psyllium husk 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.

New Users

Start with 1 dose per day; gradually increase to 3 doses per day as necessary.

Other Information

  • each tablespoon contains: potassium 30 mg; sodium 5 mg
  • store at room temperature tightly closed to protect from humidity
  • see bottom of canister for expiration date
  • contains a 100% natural, therapeutic fiber

Inactive Ingredients

citric acid, FD&C Yellow No. 6, natural and artificial orange flavor, sucrose

Questions?

1-800-983-4237

Principal Display Panel - 1.36 Kg Canister

100% Natural Psyllium
Daily fiber supplement/
Therapy for regularity

Metamucil®
MultiHealth Fiber

P&G

WORLDWIDE
PARTNER

  • Helps lower cholesterol
    to promote heart health*
  • Promotes digestive health †
  • Low glycemic index* †
  • Gluten free
    (less than 20 ppm gluten)*

    • Orange smooth

    Psyllium fiber powder
    Naturally and artificially flavored

    NET WT 48.2 OZ (3 LBS) 1.36 kg
    114     DOSES

    *See back for information about soluble fiber and heart disease and for
    information about low glycemic index and gluten.

* Please review the disclaimer below.