Label: DR. FIBRA- psyllium husk powder

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 22, 2024

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  • Drug Facts

  • Active ingredient and Purpose

    Active ingredient (in each packet)Purpose
    Psyllium seed husk 3.4 g....................Bulk-forming 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 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 reactions in people, sensitive to inhaled or ingested psyllium.

    Do not use

    • if allergic to any ingredient in this product

    Ask a doctor before use if you have

    • abdominal pain, nausea or vomiting
    • noticed a sudden change in bowel habits that persists over a period of 2 weeks
    • a sodium restricted diet

    Ask a doctor or pharmacist before use if you

    are taking any other drug. Laxatives may affect how other drugs work.

    When using this product

    • take this product 2 hours before or after other drugs

    Stop use and ask a doctor if

    • constipation lasts more than 7 days
    • rectal bleeding occurs
    • you fail to have a bowel movement after use of a laxative. These may be signs of a serious condition.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • 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.

    adults and children 12 years of age and older

    1 packet up to 3 times a day

    children 6 to under 12 years of age

    		1/2 packet up to 3 times a day

    children under 6 years of age

    		consult a doctor

    First time users: Start with the 1 packet per day, gradually increase to 3 times a day, as necessary. As your body adjust to increased fiber intake, you may experience changes in bowel habits and/or minor bloating.

  • Other information

    • each packet contains: potassium 36 mg; sodium 178 mg
    • store below 86°F (30°C)
  • Inactive ingredients

    anhydrous citric acid, FD&C yellow #6, flavors, povidone k-30, sodium bicarbonate, sucralose

  • Questions?

    +1-866-359-3478 (M-F) 9 AM - 5 PM EST or www.pharmadel.com

  • Dist. by:

    Pharmadel LLC.

    New Castle, DE 19720

  • Principal Display Panel

    Dr Fibra PDP BOX

  • INGREDIENTS AND APPEARANCE
    DR. FIBRA 
    psyllium husk powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-418
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK3.4 g
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorbrownScore    
    ShapeSize
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55758-418-1010 in 1 BOX06/30/2024
    11 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00706/30/2024
    Labeler - Pharmadel LLC (030129680)
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