Food Allergy - additive

Food Allergy - additive
SPL v1
SPL
SPL Set ID ed359bb8-4e91-1486-1dc0-6d39e6ed1f54
Route
ORAL
Published
Effective Date 2014-11-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Egg (60 [hp_X]) Fd&c Yellow No. 5 (15 [hp_X]) D&c Yellow No. 10 (10 [hp_X]) Food Yellow 3 Free Acid (3 [hp_X]) Carmoisine Amaranth Acid Ponceau 4r Tetraiodofluorescein Acid Red 1 Fd&c Blue No. 2 Sodium Acid Green 50 Benzoic Acid Potassium Propylparaben 2-phenylphenol Nitrite Ion Ascorbic Acid Tripolyphosphate Ion Aspartame Glutamic Acid Beef Pork Lamb Chicken Turkey Quahog, Unspecified Crab Leg, Unspecified Oyster, Unspecified Shrimp, Unspecified Scallop, Unspecified Amanita Muscaria Fruiting Body Onion Garlic Anacardium Occidentale Fruit Lycoperdon Utriforme Fruiting Body Caffeine Capsicum Cinnamon Cynara Scolymus Leaf Alpine Strawberry Abrus Precatorius Seed Glycyrrhiza Glabra Mentha Piperita Nutmeg Anhydrous Lactose Black Mustard Seed Solanum Nigrum Whole Allylthiourea Ustilago Maydis Ginger Brazil Nut Hazelnut, Unspecified Peanut Trout, Unspecified Cod, Unspecified Tuna, Unspecified Salmon, Unspecified Herring, Unspecified Histamine Solanum Lycopersicum Saccharin Solanum Tuberosum Saccharomyces Cerevisiae Aconitum Napellus Antimony Cation (3+) Arsenic Cation (3+) Baptisia Tinctoria Root Cinchona Officinalis Bark Gelsemium Sempervirens Root Ipecac Lachesis Muta Venom Ledum Palustre Twig Lycopodium Clavatum Spore Chloride Ion Phosphorus Podophyllum Pulsatilla Vulgaris Toxicodendron Pubescens Leaf Sepia Officinalis Juice Sulfur Urtica Urens Iris Versicolor Root Solidago Virgaurea Flowering Top
Inactive Ingredients
Sucrose

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2011-03-01
Description

Formulated for associated symptoms such as itching, swelling, headaches, labored breathing and digestive upset.

Purpose

Formulated for associated symptoms such as itching, swelling, headaches, labored breathing and digestive upset.

Medication Information

Purpose

Formulated for associated symptoms such as itching, swelling, headaches, labored breathing and digestive upset.

Description

Formulated for associated symptoms such as itching, swelling, headaches, labored breathing and digestive upset.

Package Label

Warnings Section

Warning:  Keep out of reach of children.  Do not use if tamper-evident seal is broken or missing.  If symptoms worsen or persist for more than a few  days, consult a doctor.  If pregnant or breast-feeding, ask a doctor before use.

Questions Section

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012

Questions?  1.800.448.7256 

Otc Purpose Section

Formulated for associated symptoms such as itching, swelling, headaches, labored breathing and digestive upset.

Inactive Ingredient Section

Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.

Indications & Usage Section

Formulated for associated symptoms such as itching, swelling, headaches, labored breathing and digestive upset.

Dosage & Administration Section

Directions:   Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) as needed or as directed by a health professional.  Under age 2, crush/dissolve pellets in purified water.  Sensitive persons begin with 1 pellet and gradually increase to full dose.

Otc Active Ingredient Section

Allersodes 60x, Allersodes 15x,Histaminum hydrochloricum 15x, Lycopersicum 15x, Saccharinum 15x, Sac. lac. 15x, Solanum tub. 15x, Torula cerevisiae 15x, Ustilago maidis 15x, Aconitum nap. 10x, Antimon.crud. 10x, Arsenicum alb. 10x, Baptisia 10x, Cinchona 10x, Gelsemium 10x, Ipecac. 10x, Lachesis 10x, Ledum 10x, Lycopodium 10x, Nat. mur. 10x, Phos. 10x, Podoph. pelt. 10x, Pulsatilla 10x, Rhus tox. 10x, Sepia 10x, Sulphur 10x, Urtica ur. 10x, Iris vers. 3x, Solidago 3x.

Otc Pregnancy Or Breast Feeding Section

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

Otc Keep Out of Reach of Children Section

Keep out of reach of children.

Structured Label Content

Package Label (PACKAGE LABEL)

Warnings Section (WARNINGS SECTION)

Warning:  Keep out of reach of children.  Do not use if tamper-evident seal is broken or missing.  If symptoms worsen or persist for more than a few  days, consult a doctor.  If pregnant or breast-feeding, ask a doctor before use.

Questions Section (QUESTIONS SECTION)

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012

Questions?  1.800.448.7256 

Otc Purpose Section (OTC - PURPOSE SECTION)

Formulated for associated symptoms such as itching, swelling, headaches, labored breathing and digestive upset.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Formulated for associated symptoms such as itching, swelling, headaches, labored breathing and digestive upset.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions:   Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) as needed or as directed by a health professional.  Under age 2, crush/dissolve pellets in purified water.  Sensitive persons begin with 1 pellet and gradually increase to full dose.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Allersodes 60x, Allersodes 15x,Histaminum hydrochloricum 15x, Lycopersicum 15x, Saccharinum 15x, Sac. lac. 15x, Solanum tub. 15x, Torula cerevisiae 15x, Ustilago maidis 15x, Aconitum nap. 10x, Antimon.crud. 10x, Arsenicum alb. 10x, Baptisia 10x, Cinchona 10x, Gelsemium 10x, Ipecac. 10x, Lachesis 10x, Ledum 10x, Lycopodium 10x, Nat. mur. 10x, Phos. 10x, Podoph. pelt. 10x, Pulsatilla 10x, Rhus tox. 10x, Sepia 10x, Sulphur 10x, Urtica ur. 10x, Iris vers. 3x, Solidago 3x.

Otc Pregnancy Or Breast Feeding Section (OTC - PREGNANCY OR BREAST FEEDING SECTION)

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

Otc Keep Out of Reach of Children Section (OTC - KEEP OUT OF REACH OF CHILDREN SECTION)

Keep out of reach of children.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:09:20.970597 · Updated: 2026-03-14T23:14:31.401352