Label: WHEAT MIX 1028- wheat mix liquid

  • 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 August 15, 2019

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  • ACTIVE INGREDIENTS

    Wheat 6X, 12X, 30X

  • QUESTIONS

    Professional Formulas

    PO Box 2034 Lake Oswego, OR 97035

  • INDICATIONS

    For the temporary relief of gas, bloating, diarrhea, and itching of the nose or throat due to sensitivity to wheat.*

  • PURPOSE

    *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • WARNINGS

    Severe symptoms such as difficulty breathing, facial swelling, dizziness, confusion, and hives may be life-threatening and require immediate emergency care. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use.

    Keep out of the reach of children.

    If pregnant or breastfeeding, ask a healthcare professional before use.

  • DIRECTIONS

    Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 to 15 drops up to 3 times per day. For desensitization, begin with 1 to 5 drops daily, increasing to the standard dose gradually to avoid symptom expression; after 1 to 3 months at the standard dose, decrease gradually to a maintenance dose of 10 to 15 drops weekly. Consult a physician for use in children under 12 years of age.

  • OTHER INFORMATION

    Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.

  • INACTIVE INGREDIENTS

    20% ethanol, purified water.

  • LABEL

    Est 1985

    Professional Formulas

    Complementary Health

    Wheat Mix

    Homeopathic Remedy

    2 FL. OZ. (59 mL)

    Label image

  • INGREDIENTS AND APPEARANCE
    WHEAT MIX  1028
    wheat mix liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63083-1028
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WHEAT (UNII: 4J2I0SN84Y) (WHEAT - UNII:4J2I0SN84Y) WHEAT6 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63083-1028-259 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product08/15/1985
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/15/1984
    Labeler - Professional Complementary Health Formulas (167339027)
    Registrant - Natural Pharmaceutical Manufacturing (827104258)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natural Pharmaceutical Manufacturing827104258manufacture(63083-1028)
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