Label: NATURAL DAILY FIBER- psyllium husk capsule

  • 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 24, 2020

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each capsule)

    Psyllium husk approximately 0.52 g

  • Purpose

    Fiber Laxative

  • Uses

    effective in treating occasional constipation and restoring regularity
  • 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

    Take this product 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
    Adults 12 years and older: 5 capsules with 8 oz of liquid (swallow 1 capsule at a time) at the first sign of irregularity. Can be taken up to 3 times daily. Generally produces effect in 12-72 hours.
    Children 12 years and under: Ask a doctor
    Laxatives, including bulk fibers, 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.

    HOW TO TAKE THIS PRODUCT

    (For adults 12 years and older)

    2 to 5 capsules

    DIGESTIVE HEALTH

    by promoting regularity

    up to 4 times per day

    5 capsules

    HEART HEALTH by lowering cholesterol

    MAINTENANCE OF HEALTHY BLOOD SUGARS LEVELS take before each meal

  • Other information

    each capsule contains: potassium 5 mg
    capsules are sealed using a band around the middle
    store at room temperature tightly closed to protect from humidity
    contains a 100% natural therapeutic fiber
    do not use if printed inner seal is broken or missing
  • Inactive ingredients

    caramel color, edible ink, gelatin, polysorbate 80

    Questions or comments?

    1-866-467-2748

  • PRINCIPAL DISPLAY PANEL

    CVS Health ™

    Compare to the active ingredient in Metamucil® capsules 3 in 1 MultiHealth Fiber ‡

    Natural Daily Fiber

    100% NATURAL PSYLLIUM HUSK

    FIBER LAXATIVE/DIETARY SUPPLEMENT

    THERAPY FOR REGULARITY

    Helps maintain blood sugar levels as part of your diet**
    Helps lower cholesterol to promote heart health†
    Promotes digestive health**
    Gluten- Free

    160 CAPSULES

    †See back for information about soluble fiber and heart disease.

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    © 2015 CVS/pharmacy

    CVS.com® 1-800-SHOP CVS

    ** 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.

    ‡This product is not manufactured or distributed by Procter & Gamble, the distributor of Metamucil ®Capsules.

    CVS Health Natural Daily Fiber160 Capsules
  • INGREDIENTS AND APPEARANCE
    NATURAL DAILY FIBER 
    psyllium husk capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-219
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Psyllium Husk (UNII: 0SHO53407G) (Psyllium Husk - UNII:0SHO53407G) Psyllium Husk0.52 g
    Inactive Ingredients
    Ingredient NameStrength
    CARAMEL (UNII: T9D99G2B1R)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Product Characteristics
    ColorBROWNScoreno score
    ShapeCAPSULESize21mm
    FlavorImprint Code FC119
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-219-16160 in 1 BOTTLE; Type 0: Not a Combination Product06/14/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33406/14/2017
    Labeler - CVS Pharmacy,Inc. (062312574)