GLUTEN MIX 1027- gluten mix liquid

Gluten Mix by

Drug Labeling and Warnings

Gluten Mix by is a Homeopathic medication manufactured, distributed, or labeled by Professional Complementary Health Formulas, Natural Pharmaceutical Manufacturing. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Gluten 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 gluten.*

PURPOSE

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

WARNINGS

In case of overdose, get medical help or contact a poison control center right away.

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

Gluten Mix

Homeopathic Remedy

2 FL. OZ. (59 mL)

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)