Label: METAMUCIL THERAPY FOR REGULARITY- psyllium husk powder

  • NDC Code(s): 37000-024-04, 37000-024-10
  • 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 June 14, 2022

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each TEASPOON)

    Psyllium husk approximately 3.4 g

  • Purpose

    Fiber laxative

  • Uses

    • for relief of occasional constipation (irregularity). This product generally produces bowel movement in 12 to 72 hours.
  • 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. Stir briskly and drink promptly. If mixture thickens, add more liquid and stir. For a lighter flavor experience and thinner drink, use more water.

    Adults 12 yrs. & older

    1 packet in 8 oz of liquid at the first sign of irregularity.

    Can be taken up to 3 times daily.

    6 – 11 yrs.1/2 packet in 8 oz of liquid, up to 3 times daily
    Under 6 yrs.Consult a doctor

    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.

    New Users

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

  • Other information

    • each packet contains: potassium 30 mg; sodium 5 mg
    • PHENYLKETONURICS: CONTAINS PHENYLALANINE, 25 mg per packet
    • Store below 86º F (30º C)
  • Inactive ingredients

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

  • Questions?

    1-800-983-4237

    www.pg.com

    www.metamucil.com

  • SPL UNCLASSIFIED SECTION

    DIST. BY PROCTER & GAMBLE,

    CINCINNATI OH 45202

    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 ALLERT:

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

    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. Take
    this product 2 or more hours before or after other drugs. Laxatives may affect how
    other drugs work.

    Stop use and ask a doctor if


    • constipation lasts more than 7 days
    • rectal bleeding occurs
    • you fail to have a bowel movement
    These may be signs of a serious condition.

    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.

  • PRINCIPAL DISPLAY PANEL

    MetaMUCIL

    PSYLLIUM FIBER SUPPLEMENT THERAPY FOR IRREGULARITY

    on-the-go!

    4-in-1 FIBER

    HELPS SUPPORT:

    Appetite Control*

    Heart Health by Lowering Cholesterol†

    Healthy Blood Sugar Levels*

    Digestive Health *

    SUGAR-FREE

    not a low calorie food

    orange smooth

    See back for information about soluble fiber and heart disease



    ORANGE fiber powder / naturally and artificially flavored

    30-0.21 OZ (5.8g) POWDER PACKETS/NET WT 6.20z (176g)

    024

  • INGREDIENTS AND APPEARANCE
    METAMUCIL  THERAPY FOR REGULARITY
    psyllium husk powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-024
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK3.4 g  in 5.8 g
    Inactive Ingredients
    Ingredient NameStrength
    ASPARTAME (UNII: Z0H242BBR1)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Product Characteristics
    ColorbrownScore    
    ShapeSize
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-024-0430 in 1 CARTON12/15/1994
    1NDC:37000-024-100.021 g in 1 POUCH; Type 0: Not a Combination Product
    2NDC:37000-024-100.021 g in 1 POUCH; Type 0: Not a Combination Product12/15/1994
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33412/15/1994
    Labeler - The Procter & Gamble Manufacturing Company (004238200)