Label: GLUTEN SENSITIVITY FORMULA- lycopodium clavatum, pulsatilla capsule

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated February 8, 2023

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

  • ACTIVE INGREDIENTS:

    Lycopodium Clavatum 12X, Pulsatilla (Pratensis) 12X.

  • INDICATIONS:

    For temporary relief of symptoms associated with constipation, bloating, diarrhea and other symptoms of poor digestion.

  • WARNINGS:

    If pregnant or breastfeeding, ask a health professional before use. If you have an allergy to fish (including salmon), you should not use this product.

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

    Do not use if tamper evident seal is broken or missing.

    Store in a cool, dry place.

  • KEEP OUT OF REACH OF CHILDREN:

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

  • DIRECTIONS:

    Adults take 6 capsules one time daily. Children under 30 lbs take 2 capsules one time daily, up to 60 lbs take 3 capsules one time daily, up to 90 lbs take 4 capsules one time daily. Can take capsule apart and mix powder in juice. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    For temporary relief of symptoms associated with constipation, bloating, diarrhea and other symptoms of poor digestion.

  • INACTIVE INGREDIENTS:

    Aronia (Berry), Capsule (Gelatin), DNA (Deoxyribonucleic acidum sodium salt)**, Folic Acid, L-Carnosine, Rice Flour, RNA (Ribonucleic acid sodium salt), Vitamin D3 (from Cholecalciferol).

    **Contains Salmon

  • QUESTIONS:

    Distributed by:

    Herbs & More of Tulsa

    6538 E. 31st Street

    Tulsa, OK 74145

    (918) 492-2400

    www.thewisealternative.com

  • PACKAGE LABEL DISPLAY:

    The Wise Alternative

    Gluten Sensitivity Formula

    Homeopathic 180 Capsules

    Gluten Sensitivity Formula

  • INGREDIENTS AND APPEARANCE
    GLUTEN SENSITIVITY FORMULA 
    lycopodium clavatum, pulsatilla capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71284-0001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE12 [hp_X]
    ANEMONE PRATENSIS (UNII: 8E272251DI) (ANEMONE PRATENSIS - UNII:8E272251DI) ANEMONE PRATENSIS12 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    ARONIA MELANOCARPA FRUIT (UNII: S935718Z2Q)  
    GELATIN (UNII: 2G86QN327L)  
    ONCORHYNCHUS MASOU SPERM DNA (UNII: 1SI16O1B9R)  
    FOLIC ACID (UNII: 935E97BOY8)  
    CARNOSINE (UNII: 8HO6PVN24W)  
    BROWN RICE (UNII: 659G217HPG)  
    CYBERLINDNERA JADINII RNA (UNII: 5620EH64M4)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapecapsuleSize23mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71284-0001-1180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/23/201812/17/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/23/201812/17/2024
    Labeler - Herbs & More of Tulsa (084990485)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(71284-0001) , api manufacture(71284-0001) , label(71284-0001) , pack(71284-0001)