Label: METAMUCIL THERAPY FOR REGULARITY- psyllium husk powder

  • NDC Code(s): 37000-023-01, 37000-023-04
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 4, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each PACKET)

    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.
  • Warnings

    Choking:

    Taking this product without adequate fluid may cause it to swell and block your throat or esophagus andmay 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 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.

  • OVERDOSAGE

    In case of overdose, contact a doctor or a PoisonControl 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. 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. & older1 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.

  • Other information

    • each packet contains:potassium 30 mg; sodium 5 mg
    • Store below 86° F (30° C)

  • Inactive ingredients

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

  • Questions?

    1-800-983-4237

  • SPL UNCLASSIFIED SECTION

    INDIVIDUAL PACKETS SEALED FOR YOUR PROTECTION

  • SPL UNCLASSIFIED SECTION

    DIST. BY PROCTER & GAMBLE

    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL

    MetaMUCIL ®

    PSYLLIUM FIBER SUPPLEMENT THERAPY FOR REGULARITY

    on-the-go!

    30 packets

    4-in-1 FIBER

    HELPS SUPPORT:

    Appetite Control*
    Heart Health by Lowering Cholesterol†
    Healthy Blood Sugar Levels*
    Digestive Health*

    made with REAL SUGAR

    ORANGE

    fiber powder / naturally and artificially flavored

    †See back for information about soluble fiber and heart disease

    30 - 0.43 OZ (12 g) POWDER PACKETS/NET WT 12.9 OZ (366 g)

    *These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

    023

  • 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
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    SUCROSE (UNII: C151H8M554)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Product Characteristics
    ColorbrownScore    
    ShapeSize
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-023-0112 g in 1 PACKET; Type 0: Not a Combination Product12/15/1995
    2NDC:37000-023-0430 in 1 CARTON03/31/1989
    212 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00703/31/1989
    Labeler - The Procter & Gamble Manufacturing Company (004238200)