Label: CVS NATURAL FIBER EFFERVESCENT- psyllium husk powder

  • Category: HUMAN OTC DRUG LABEL

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 February 28, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each PACKET)

    Psyllium husk approximately 3.4 g

  • Purpose

    Fiber therapy for regularity

  • Uses

    •
    for relief of occasional constipation (irregularity)
  • 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 doctor or a Poison Control Center right away. (1-800-222-1222)

  • Directions

    Put one packet 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. & older:

    1 packet 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.

    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 packet contains: potassium 30 mg; sodium 194.0 mg
    •
    PHENYLKETONURICS: CONTAINS PHENYLALANINE, 29.0 mg per teaspoon
    •
    store at room temperature tightly closed to protect from humidity
    •
    do not use if printed package is torn or punctured
    •
    contains a 100% natural, therapeutic fiber
  • Inactive ingredients

    anhydrous citric acid, aspartame, flavors, sodium bicarbonate, sucralose, yellow no 6.

  • SPL UNCLASSIFIED SECTION

    Distributed By: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket RI 02895

    CVS.com

    1-800-SHOP CVS

  • PRINCIPAL DISPLAY PANEL

    Natural Daily Fiber Effervescent

    Smooth Dissolving
    100% Natural Psyllium Husk Fiber Supplement

    Compare to the active ingredient in Metamucil® MultiHealth Fiber

    Sugar Free

    Therapy for regularity as part of a healthy lifestyle

    Promotes digestive health

    Helps lower cholesterol to promote heart health

    Orange

    Naturally and Artificially Flavored

    30 Packets

    CVS Daily Fiber Effervescent
  • INGREDIENTS AND APPEARANCE
    CVS  NATURAL FIBER EFFERVESCENT
    psyllium husk powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-535
    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)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorBROWNScore    
    ShapeSize
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-535-3030 in 1 CARTON
    13.4 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33402/28/2014
    Labeler - CVS Pharmacy (062312574)
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