Label: DISCOUNT DRUG MART SUGAR FREE- psyllium husk natural fiber powder

  • 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 August 21, 2021

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)
    generally produces bowel movement 12-72 hours
  • 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, 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 thickens, add more liquid and stir.

    Adults & Children 12 years & older:

    1 rounded teaspoon in 8 ounces of liquid at the first sign of irregularity. Can be taken up to 3 times daily.

    Children 6-11 yrs :

    ½ adult dose in 8 ounces of liquid, up to 3 times daily

    Children 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 serving per day; gradually increased 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; 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 6, maltodextrin, natural and artificial orange flavor, silica.

  • PRINCIPAL DISPLAY PANEL

    NDC 53943-551-72

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

    SMOOTH TEXTURE

    Fiber Therapy

    POWDER

    Fiber Laxative/Fiber Supplement

    100% Natural Psyllium Husk

    SUGAR FREE

    NOT A LOW CALORIE FOOD

    +
    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**

    Orange Flavor

    Naturally and Artificially Flavored

    72 TEASPOON DOSES

    NET WT 15 OZ (425 g)

    Fill controlled by weight, not volume

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

    *This product is not manufactured or distributed by Procter & Gamble, the distributor of METAMUCIL®.

    SATISFACTION GUARANTEED IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO STORE, SEND REASON FOR DISSATISFACTION, NAME, ADDRESS AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DR., MEDINA, OHIO 44256.

    Distributed By:

    Drug Mart-Food Fair

    211 Commerce Dr.

    Medina, Ohio 44256

    Smooth Texture Fiber Therapy
  • INGREDIENTS AND APPEARANCE
    DISCOUNT DRUG MART  SUGAR FREE
    psyllium husk natural fiber powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-551
    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)  
    Product Characteristics
    ColorBROWN (Light Yellowish) Score    
    ShapeSize
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53943-551-72425 g in 1 BOTTLE; Type 0: Not a Combination Product05/16/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33405/16/2019
    Labeler - DISCOUNT DRUG MART (047741335)