FDA.reportPublic FDA data

Dairy-Grain-Nightshade

Manufacturer
Newton Laboratories, Inc.
Effective date
2025-07-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:34:33

Key Label Information#

Active Ingredients And Purpose

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Iris versicolor 6x, Solidago virgaurea 6x, Antimonium crudum 15x, Argentum nitricum 15x, Arsenicum album 15x, Avena sativa 15x, Baptisia tinctoria 15x, Belladonna 15x, Bryonia 15x, Capsicum annuum 15x, Carduus benedictus 15x, Cinchona officinalis 15x, Dulcamara 15x, Fagopyrum esculentum 15x, Gelsemium sempervirens 15x, Hyoscyamus niger 15x, Ipecacuanha 15x, Lac vaccinum 15x, Lachesis mutus 15x, Lycopodium clavatum 15x, Natrum muriaticum 15x, Phosphorus 15x, Podophyllum peltatum 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Saccharum lactis 15x, Secale cornutum 15x, Sepia 15x, Stramonium 15x, Tabacum 15x, Triticum repens 15x, Ustilago maidis 15x, Verbascum thapsus 15x, Lycopersicum esculentum 16x, Solanum nigrum 16x, Solanum tuberosum 16x, Stigmata maidis 16x, Torula cerevisiae 16x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with sensitivity and intolerance to dairy, grain and nightshade foods such as bloating, headache, indigestion, itching and eruptions.

Uses

INDICATIONS & USAGE SECTION

Formulated for symptoms associated with sensitivity and intolerance to dairy, grain and nightshade foods such as bloating, headache, indigestion, itching and eruptions.

Warnings

WARNINGS SECTION

WARNINGS: 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Directions And Dosage

DOSAGE & ADMINISTRATION SECTION

Directions : Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional.

Other Label Information

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

QUESTIONS SECTION

newtonlabs.net - Questions? 800.448.7256 Newton Laboratories, Inc. FDA Est # 1051203 Conyers, GA 30013

PACKAGE LABEL

Label Images#

R087-L01
R087-L01

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
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6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
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419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4832-1Dairy-Grain-Nightshade30 mL in 1 BOTTLE, GLASSLIQUID303

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-483255714-4832-1

Ingredients#

Name, UNII, Kind table
NameUNIIKind
IRIS VERSICOLOR ROOTX43D4L3DQCACTIB
AVENA SATIVA FLOWERING TOPMA9CQJ3F7FACTIB
CAPSICUM00UK7646FGACTIB
CENTAUREA BENEDICTA6L5ZL09795ACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
CORN SILK7D3VB244UXACTIB
ANTIMONY TRISULFIDEF79059A38UACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
HYOSCYAMUS NIGER4WRK2153H3ACTIB
IPECAC62I3C8233LACTIB
ELYMUS REPENS ROOT3IXW0F6P8WACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
SOLANUM DULCAMARA TOPKPS1B1162NACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
FAGOPYRUM ESCULENTUMB10M69172NACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
DATURA STRAMONIUMG6W4F0V8Z3ACTIB
USTILAGO MAYDIS4K7Z7K7SWGACTIB
SOLANUM LYCOPERSICUM0243Q4990LACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
SOLANUM TUBEROSUM2A8I57T4MXACTIB
SACCHAROMYCES CEREVISIAE978D8U419HACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
CLAVICEPS PURPUREA SCLEROTIUM01G9XEA93NACTIB
SOLIDAGO VIRGAUREA FLOWERING TOP5405K23S50ACTIB
SILVER NITRATE95IT3W8JZEACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
TOBACCO LEAF6YR2608RSUACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
PHOSPHORUS27YLU75U4WACTIB
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GACTIB
PODOPHYLLUM2S713A4VP3ACTIB
VERBASCUM THAPSUSC9TD27U172ACTIB
SOLANUM NIGRUM WHOLE0FMD6WV47MACTIB
COW MILK917J3173FTACTIB

Complete SPL Sections#

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

Formulated for symptoms associated with sensitivity and intolerance to dairy, grain and nightshade foods such as bloating, headache, indigestion, itching and eruptions.

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

Directions : Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional.

OTC - ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Iris versicolor 6x, Solidago virgaurea 6x, Antimonium crudum 15x, Argentum nitricum 15x, Arsenicum album 15x, Avena sativa 15x, Baptisia tinctoria 15x, Belladonna 15x, Bryonia 15x, Capsicum annuum 15x, Carduus benedictus 15x, Cinchona officinalis 15x, Dulcamara 15x, Fagopyrum esculentum 15x, Gelsemium sempervirens 15x, Hyoscyamus niger 15x, Ipecacuanha 15x, Lac vaccinum 15x, Lachesis mutus 15x, Lycopodium clavatum 15x, Natrum muriaticum 15x, Phosphorus 15x, Podophyllum peltatum 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Saccharum lactis 15x, Secale cornutum 15x, Sepia 15x, Stramonium 15x, Tabacum 15x, Triticum repens 15x, Ustilago maidis 15x, Verbascum thapsus 15x, Lycopersicum esculentum 16x, Solanum nigrum 16x, Solanum tuberosum 16x, Stigmata maidis 16x, Torula cerevisiae 16x.

OTC - PURPOSE SECTION

OTC - PURPOSE SECTION

Formulated for symptoms associated with sensitivity and intolerance to dairy, grain and nightshade foods such as bloating, headache, indigestion, itching and eruptions.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net - Questions? 800.448.7256 Newton Laboratories, Inc. FDA Est # 1051203 Conyers, GA 30013

WARNINGS SECTION

WARNINGS SECTION

WARNINGS: 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.

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.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document#

Source XML