Label: GLUTEN MIX 1027- gluten mix liquid
- NDC Code(s): 63083-1027-2
- Packager: Professional Complementary Health Formulas
- 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
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
- INACTIVE INGREDIENTS
INGREDIENTS AND APPEARANCE
GLUTEN MIX 1027
gluten mix liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63083-1027 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WHEAT GLUTEN (UNII: 1534K8653J) (WHEAT GLUTEN - UNII:1534K8653J) WHEAT GLUTEN 6 [hp_X] in 59 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63083-1027-2 59 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 08/15/1985 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/15/1984 Labeler - Professional Complementary Health Formulas (167339027) Registrant - Natural Pharmaceutical Manufacturing (015624923) Establishment Name Address ID/FEI Business Operations Natural Pharmaceutical Manufacturing 015624923 manufacture(63083-1027)