Label: RITE AID FIBER THERAPY- psyllium husk powder, for suspension

  • 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 October 25, 2021

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

  • Active ingredient (in each TEASPOON)

    Psyllium husk approximately 3.4 g

  • Purpose

    Fiber therapy for regularity

  • Uses

    for relief of occasional constipation (irregularity)
  • Warnings

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

    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
    a sudden change in bowel habits persisting for 2 weeks

    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, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

  • 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 thickness, add more liquid and stir.

    Adults 12 years & older:

    1 rounded TEASPOON in 8 ounces of liquid at the signs of irregularity. Can be taken up to 3 times daily. Generally produces effect in 12-72 hours.

    Children 6-11 yrs:

    ½ adult dose in 8 ounces 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.

    New Users: Start with 1 serving per day; gradually increase to desired daily intake. You may initially experience changes in bowel habits or minor bloating, as your body adjusts to increased fiber intake.

  • Other information

    each teaspoon contains: potassium 35 mg and sodium 5 mg
    PHENYLKETONURICS:CONTAINS PHENYLALANINE, 25 mg per teaspoon
    Store at room temperature. Keep the container tightly closed to protect from humidity
    Contains a 100% natural, therapeutic fiber
  • Inactive ingredients

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

    Questions or comments?

    1-866-467-2748

  • Principal Display Panel

    RITE AID PHARMACY®

    NDC# 11822-5151-4

    Compare to the fiber content in Metamucil® 4 in 1 MultiHealth Fiber!™*

    FIBER THERAPY

    100% NATURAL PSYLLIUM HUSK

    MULTI-BENEFIT DAILY FIBER SUPPLEMENT

    Helps you feel less hungry between meals**

    Helps Maintain Healthy Blood Sugar Levels as Part of Your Diet**

    Helps Lower Cholesterol to Promote Heart Health

    Promotes Digestive Health**

    Gluten Free

    SUGAR FREE

    NOT A LOW CALORIE FOOD

    SMOOTH ORANGE

    NATURALLY & ARTIFICIALLY FLAVORED

    **SEE BACK FOR INFORMATION ABOUT SOLUBLE FIBER AND HEART DISEASE.

    114 TEASPOON DOSES

    SERVING SIZE VARIES. SEE DIRECTIONS ON BACK PANEL FOR MORE INFORMATION

    K PAREVE

    NET WT. 23.3 OZ (1.4 LB) 660g

    FILL CONTROLLED BY WEIGHT, NOT VOLUME

    †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.

    TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS BROKEN OR MISSING

    *This product is not manufactured or distributed by Procter & Gamble, the distributor, the distributor of Metamucil® 4 in 1 MultiHealth Fiber!™*

    DISTRIBUTED BY:

    RITE AID

    30 HUNTER LANE,

    CAMP HILL, PA 17011

    www.riteaid.com

    Rite Aid Fiber Therapy Powder 114 teasppon doses
  • INGREDIENTS AND APPEARANCE
    RITE AID FIBER THERAPY 
    psyllium husk powder, for suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-5151
    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)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorBROWNScore    
    ShapeSize
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-5151-4660 g in 1 CANISTER; Type 0: Not a Combination Product03/13/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33403/13/2019
    Labeler - RITE AID CORPORATION (014578892)