Wheat Mix

Manufacturer
Professional Complementary Health Formulas | Natural Pharmaceutical Manufacturing
Effective date
2019-08-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:14:44

Label at a glance#

ProductWheat Mix 1028
Active ingredientWHEAT
Label structure9 sections

Dosage and administration

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 1...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Wheat 6X, 12X, 30X

QUESTIONS

OTC - QUESTIONS SECTION

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

INDICATIONS

INDICATIONS & USAGE SECTION

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

OTC - PURPOSE SECTION

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

WARNINGS

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

20% ethanol, purified water.

LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Est 1985

Professional Formulas

Complementary Health

Wheat Mix

Homeopathic Remedy

2 FL. OZ. (59 mL)

Label imageLabel image

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63083-1028-22022-07-29C16284748780-1e4f33bdf-b27a-d8a0-e053-dadaa90a6e4eAWHEAT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63083-1028-2Wheat Mix102859 mL in 1 BOTTLE, DROPPERLIQUID591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63083-1028WHEAT MIX 1028 (WHEAT MIX) LIQUID [PROFESSIONAL COMPLEMENTARY HEALTH FORMULAS]1Legacy NDC, 1 package rows20210720_484d0e33-6232-42ba-a147-7691be3fe019.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63083-102863083-1028-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
WHEAT4J2I0SN84YACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0de48ad7-6ac3-4224-a2e5-bc4a3c29117d484d0e33-6232-42ba-a147-7691be3fe0192019-08-15WarningsExact identifier
spl id: 0de48ad7-6ac3-4224-a2e5-bc4a3c29117d
spl set id: 484d0e33-6232-42ba-a147-7691be3fe019

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.