DRUG FACTS:

Manufacturer
Nutritional Specialties, Inc.
Effective date
2026-03-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:38:15

Label at a glance#

ProductAddex
Active ingredientARCTIUM LAPPA ROOT, PLANTAGO MAJOR WHOLE, TARAXACUM OFFICINALE, GLYPHOSATE
Label structure9 sections

Indications and uses

Aids in temporary relief of symptoms from pesticide exposure such as •itching, •hives, •nasal •congestion, •muscle weakness, •irritability, •headaches, •gastrointestinal upset and •difficulty sleeping.† †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Dosage and administration

• Adults: 2 to 3 sprays orally, three times daily. Children under twelve one half adult dosage. • Do not take within 15 minutes of consuming food, beverage or brushing teeth. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

(in each spray) Glyphosate 12C, Lappa Major 3X, Plantago Major 3X, Taraxacum Officinale 3X.

PURPOSE:

OTC - PURPOSE SECTION

Glyphosate – Assists in Relieving Gastrointestinal Upset, Headaches, Hives, and Itching,† Lappa Major - Assists in Relieving Gastrointestinal Upset, Headaches, Hives, and Itching,† Plantago Major – Assists in Relieving Difficulty Sleeping, Gastrointestinal Upset, Headaches, Hives, Irritability, Itching, Muscle Weakness, and Nasal Congestion,† Taraxacum Officinale - Assists in Relieving Difficulty Sleeping, Gastrointestinal Upset, Headaches, Hives, Irritability, Itching, and Muscle Weakness†

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

USES:

INDICATIONS & USAGE SECTION

Aids in temporary relief of symptoms from pesticide exposure such as •itching, •hives, •nasal •congestion, •muscle weakness, •irritability, •headaches, •gastrointestinal upset and •difficulty sleeping.†

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

WARNINGS:

WARNINGS SECTION

If pregnant or breast-feeding, ask a health professional before use.

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

If condition worsens, seek medical attention.

KEEP OUT OF REACH OF CHILDREN

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

Store in a cool place after opening

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

• Adults: 2 to 3 sprays orally, three times daily. Children under twelve one half adult dosage.

• Do not take within 15 minutes of consuming food, beverage or brushing teeth.

Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Alcohol USP 20%, Purified Water USP.

QUESTIONS:

OTC - QUESTIONS SECTION

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com

1-800-245-1313

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Professional

Health Products

HOMEOPATHIC

NDC 83027-0044-1

ADDEX

2 FL. OZ. (60 ml)

ADDEXADDEX

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130649818024015GTIN-13: 0649818024015
EAN-13: 0649818024015
GTIN-12: 649818024015
UPC-A: 649818024015
GTIN storage (14 digits): 00649818024015
NSPC0053 Addex 2oz 12-17-25.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83027-0044-1Addex60 mL in 1 BOTTLE, SPRAYSPRAY602

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83027-004483027-0044-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

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
AddexLAPPA MAJOR, PLANTAGO MAJOR, TARAXACUM OFFICINALE, GLYPHOSATENutritional Specialties, Inc.50318603-4f2e-461a-8efb-98f3873836b92026-03-31WarningsExact identifier
ndc (package): 83027-0044-1
ndc (product): 83027-0044
ndc11 (package): 83027004401
spl id: d983d2f4-ec2a-4c36-9a4e-abb3640a32fa
spl set id: 50318603-4f2e-461a-8efb-98f3873836b9

Reported adverse events (FAERS/openFDA)#

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