Label: GOOD NEIGHBOR PHARMACY NATURAL 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 May 29, 2015

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

  • Drug Facts

    Active ingredient (in each capsule)

    Psyllium husk approx. 0.52 g

    Purpose

    Bulk-forming laxative

    Uses

    • relieves occasional constipation and helps restore regularity
    • this product generally produces bowel movement in 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

    Allegry allert

    this product may cause an allergic reaction in people sensitive to inhaled or ingested psyllium

    Ask a doctor before use if you have

    • abdominal pain, nausea or vomiting
    • difficulty in swallowing
    • a sudden change in bowel habits that persists over a period of 2 weeks

    Stop use and ask a doctor if

    • you fail to have a bowel movement after use or have rectal bleeding. These could be signs of a serious condition.

    •  symptoms persist more than 1 week

    Keep out of the reach of children.

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

    Directions

    • take this product (child or adult dose) with a full glass of water (8 oz.) or other fluid. Taking this product without enough liquid may cause choking. See choking warning.

    • swallow one capsule at a time

    • daily maximum 3 doses

    • dosage will vary according to diet, exercise, previous laxative use or severity of constipation

    • adults and children 12 years & older: 5 capsules, 1 to 3 times a day

    • children 6 to 11 years: consider use of powder form of product

    • children under 6 years: 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.

    Other information

    • store at room temperature

    • protect contents from moisture

    Inactive Ingredients

    acacia, black iron oxide, caramel color, gelatin, polysorbate 80.

  • Good Neighbor Pharmacy Natural Fiber

    46122010006.jpg

  • INGREDIENTS AND APPEARANCE
    GOOD NEIGHBOR PHARMACY NATURAL FIBER 
    psyllium husk capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-100
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK.52 g
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    GELATIN (UNII: 2G86QN327L)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Product Characteristics
    ColorbrownScoreno score
    ShapecapsuleSize20mm
    FlavorImprint Code G;650
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46122-100-06160 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33407/12/2010
    Labeler - AmerisourceBergen Drug Corporation (007914906)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276manufacture(46122-100) , label(46122-100)