Label: METAMUCIL THERAPY FOR REGULARITY- psyllium husk powder

  • NDC Code(s): 37000-023-04, 37000-023-05, 37000-023-06, 37000-023-07, view more
    37000-023-10
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 8, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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
  • 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.

    Allergy alert

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

    Ask a doctor before use if you have

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

    Stop use and ask a doctor if

    • constipation lasts more than 7 days
    • rectal bleeding occurs

    These may be signs of a serious condition.

    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

  • SPL UNCLASSIFIED SECTION

    Dist. by Procter & Gamble, Cincinnati OH 45202

  • 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.

    Principal Display Panel - 1.36 kg Canister
  • INGREDIENTS AND APPEARANCE
    METAMUCIL  THERAPY FOR REGULARITY
    psyllium husk powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-023
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK3.4 g  in 12 g
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorbrownScore    
    ShapeSize
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-023-071360 g in 1 CANISTER; Type 0: Not a Combination Product03/31/1989
    2NDC:37000-023-06822 g in 1 CANISTER; Type 0: Not a Combination Product03/31/1989
    3NDC:37000-023-05575 g in 1 CANISTER; Type 0: Not a Combination Product03/31/1989
    4NDC:37000-023-0430 in 1 CARTON03/31/1989
    4NDC:37000-023-1012 g in 1 POUCH; Type 0: Not a Combination Product
    5NDC:37000-023-1012 g in 1 POUCH; Type 0: Not a Combination Product03/31/1989
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33403/31/1989
    Labeler - The Procter & Gamble Manufacturing Company (004238200)