Dairy - Grain - Nightshades

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-03-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:34:38

Label at a glance#

ProductDairy - Grain - Nightshades
Active ingredientCow Milk, Skim Milk, Cow Milk Fat, Casein, Lactococcus Lactis Cultured, Aged, Casein, Lactococcus Lactis Cultured, Penicillium Roqueforti Cultured, Aged, Casein, Lactococcus Lactis Cultured, Penicillium Camemberti Cultured, Aged, Barley, Corn, Wheat Gluten, Oat, White Rice, Rye, Wheat, Atropa Belladonna, Capsicum, Solanum Dulcamara Top, Hyoscyamus Niger, Solanum Nigrum Whole, Datura Stramonium, Tobacco Leaf, Solanum Lycopersicum, Lactose, Solanum Tuberosum, Saccharomyces Cerevisiae, Ustilago Maydis, Antimony Trisulfide, Silver Nitrate, Arsenic Trioxide, Baptisia Tinctoria Root, Bryonia Alba Root, Centaurea Benedicta, Cinchona Officinalis Bark, Gelsemium Sempervirens Root, Ipecac, Lachesis Muta Venom, Sodium Chloride, Phosphorus, Podophyllum, Pulsatilla Vulgaris, Toxicodendron Pubescens Leaf, Sepia Officinalis Juice, Elymus Repens Root, Verbascum Thapsus, Iris Versicolor Root, Solidago Virgaurea Flowering Top, Lycopodium Clavatum Spore
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

 Formulated for symptoms associated with sensitivity and intolerance to dairy, grain and nightshade foods.

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 , Lycopersicum 15x, Sac. lac. 15x, Solanum tub. 15x, Torula cerevisiae 15x, Ustilago maidis 15x, Antimon. crud. 10x, Arg. nit. 10x, Arsenicum alb. 10x, Baptisia 10x, Bryonia 10x, Carduus ben. 10x, Cinchona 10x, Gelsemium 10x, Ipecac. 10x, Lachesis 10x, Lycopodium 10x, Nat. mur. 10x, Phos. 10x, Podoph. pelt.10x, Pulsatilla 10x, Rhus tox. 10x, Sepia 10x, Triticum 10x, Verbascum 10x, Iris vers. 3x, Solidago 3x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with sensitivity and intolerance to dairy, grain and nightshade foods.

INACTIVE INGREDIENT SECTION

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

QUESTIONS SECTION

OTC - QUESTIONS SECTION

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256

WARNINGS SECTION

Warning:  Keep our 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package label
package label

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Antimony TrisulfideACTIVE INGREDIENTF79059A38U1
Arsenic TrioxideACTIVE INGREDIENTS7V92P67HO1
Atropa BelladonnaACTIVE INGREDIENTWQZ3G9PF0H1
Baptisia Tinctoria RootACTIVE INGREDIENT5EF0HWI5WU1
BarleyACTIVE INGREDIENT5PWM7YLI7R1
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B1
CapsicumACTIVE INGREDIENT00UK7646FG1
Casein, Lactococcus Lactis Cultured, AgedACTIVE INGREDIENTCJP9NL7JSJ1
Casein, Lactococcus Lactis Cultured, Penicillium Camemberti Cultured, AgedACTIVE INGREDIENTG44KTI7KIS1
Casein, Lactococcus Lactis Cultured, Penicillium Roqueforti Cultured, AgedACTIVE INGREDIENTIYI0G2057S1
Centaurea BenedictaACTIVE INGREDIENT6L5ZL097951
Cinchona Officinalis BarkACTIVE INGREDIENTS003A158SB1
CornACTIVE INGREDIENT0N8672707O1
Cow MilkACTIVE INGREDIENT917J3173FT1
Cow Milk FatACTIVE INGREDIENT463JZS0XJ31
Datura StramoniumACTIVE INGREDIENTG6W4F0V8Z31
Elymus Repens RootACTIVE INGREDIENT3IXW0F6P8W1
Gelsemium Sempervirens RootACTIVE INGREDIENT639KR60Q1Q1
Hyoscyamus NigerACTIVE INGREDIENT4WRK2153H31
IpecacACTIVE INGREDIENT62I3C8233L1
Iris Versicolor RootACTIVE INGREDIENTX43D4L3DQC1
Lachesis Muta VenomACTIVE INGREDIENTVSW71SS07I1
LactoseACTIVE INGREDIENTJ2B2A4N98G1
Lycopodium Clavatum SporeACTIVE INGREDIENTC88X29Y4791
OatACTIVE INGREDIENTZ6J799EAJK1
PhosphorusACTIVE INGREDIENT27YLU75U4W1
PodophyllumACTIVE INGREDIENT2S713A4VP31
Pulsatilla VulgarisACTIVE INGREDIENTI76KB35JEV1
RyeACTIVE INGREDIENT0R4AQI398X1
Saccharomyces CerevisiaeACTIVE INGREDIENT978D8U419H1
Sepia Officinalis JuiceACTIVE INGREDIENTQDL83WN8C21
Silver NitrateACTIVE INGREDIENT95IT3W8JZE1
Skim MilkACTIVE INGREDIENT6A001Y4M5A1
Sodium ChlorideACTIVE INGREDIENT451W47IQ8X1
Solanum Dulcamara TopACTIVE INGREDIENTKPS1B1162N1
Solanum LycopersicumACTIVE INGREDIENT0243Q4990L1
Solanum Nigrum WholeACTIVE INGREDIENT0FMD6WV47M1
Solanum TuberosumACTIVE INGREDIENT2A8I57T4MX1
Solidago Virgaurea Flowering TopACTIVE INGREDIENT5405K23S501
Tobacco LeafACTIVE INGREDIENT6YR2608RSU1
Toxicodendron Pubescens LeafACTIVE INGREDIENT6IO182RP7A1
Ustilago MaydisACTIVE INGREDIENT4K7Z7K7SWG1
Verbascum ThapsusACTIVE INGREDIENTC9TD27U1721
WheatACTIVE INGREDIENT4J2I0SN84Y1
Wheat GlutenACTIVE INGREDIENT1534K8653J1
White RiceACTIVE INGREDIENTA195V20H7A1
Anhydrous LactoseACTIVE MOIETY3SY5LH9PMK1
Antimony Cation (3+)ACTIVE MOIETY069647RPT51
Arsenic Cation (3+)ACTIVE MOIETYC96613F5AV1
Atropa BelladonnaACTIVE MOIETYWQZ3G9PF0H1
Baptisia Tinctoria RootACTIVE MOIETY5EF0HWI5WU1
BarleyACTIVE MOIETY5PWM7YLI7R1
Bryonia Alba RootACTIVE MOIETYT7J046YI2B1
CapsicumACTIVE MOIETY00UK7646FG1
Casein, Lactococcus Lactis Cultured, AgedACTIVE MOIETYCJP9NL7JSJ1
Casein, Lactococcus Lactis Cultured, Penicillium Camemberti Cultured, AgedACTIVE MOIETYG44KTI7KIS1
Casein, Lactococcus Lactis Cultured, Penicillium Roqueforti Cultured, AgedACTIVE MOIETYIYI0G2057S1
Centaurea BenedictaACTIVE MOIETY6L5ZL097951
Chloride IonACTIVE MOIETYQ32ZN486981
Cinchona Officinalis BarkACTIVE MOIETYS003A158SB1
CornACTIVE MOIETY0N8672707O1
Cow MilkACTIVE MOIETY917J3173FT1
Cow Milk FatACTIVE MOIETY463JZS0XJ31
Datura StramoniumACTIVE MOIETYG6W4F0V8Z31
Elymus Repens RootACTIVE MOIETY3IXW0F6P8W1
Gelsemium Sempervirens RootACTIVE MOIETY639KR60Q1Q1
Hyoscyamus NigerACTIVE MOIETY4WRK2153H31
IpecacACTIVE MOIETY62I3C8233L1
Iris Versicolor RootACTIVE MOIETYX43D4L3DQC1
Lachesis Muta VenomACTIVE MOIETYVSW71SS07I1
Lycopodium Clavatum SporeACTIVE MOIETYC88X29Y4791
OatACTIVE MOIETYZ6J799EAJK1
PhosphorusACTIVE MOIETY27YLU75U4W1
PodophyllumACTIVE MOIETY2S713A4VP31
Pulsatilla VulgarisACTIVE MOIETYI76KB35JEV1
RyeACTIVE MOIETY0R4AQI398X1
Saccharomyces CerevisiaeACTIVE MOIETY978D8U419H1
Sepia Officinalis JuiceACTIVE MOIETYQDL83WN8C21
Silver CationACTIVE MOIETY57N7B0K90A1
Skim MilkACTIVE MOIETY6A001Y4M5A1
Solanum Dulcamara TopACTIVE MOIETYKPS1B1162N1
Solanum LycopersicumACTIVE MOIETY0243Q4990L1
Solanum Nigrum WholeACTIVE MOIETY0FMD6WV47M1
Solanum TuberosumACTIVE MOIETY2A8I57T4MX1
Solidago Virgaurea Flowering TopACTIVE MOIETY5405K23S501
Tobacco LeafACTIVE MOIETY6YR2608RSU1
Toxicodendron Pubescens LeafACTIVE MOIETY6IO182RP7A1
Ustilago MaydisACTIVE MOIETY4K7Z7K7SWG1
Verbascum ThapsusACTIVE MOIETYC9TD27U1721
WheatACTIVE MOIETY4J2I0SN84Y1
Wheat GlutenACTIVE MOIETY1534K8653J1
White RiceACTIVE MOIETYA195V20H7A1
SucroseINACTIVE INGREDIENTC151H8M5541

Products#

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

DailyMed product names page 1 of 2 · 54 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-231355714-2313-1, 55714-2313-2, 55714-2313-0

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 47 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 48 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SucroseSUCROSEC151H8M554TABLET, COATED / ORAL516.42 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554LOZENGE / TRANSMUCOSAL1255 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SOLUTION / RECTAL35.42 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554PASTILLE / ORAL426 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, FILM COATED, EXTENDED RELEASE / ORAL119.12 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTABLE, LIPOSOMAL / INTRAVENOUS7560 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CAPSULE, COATED PELLETS / ORAL59.8 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, FILM COATED / ORAL145 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TROCHE / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TROCHE / BUCCALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SYRUP / ORAL46400 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS308 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554LOZENGE / BUCCALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554GRANULE, FOR SUSPENSION / ORAL31885 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CAPSULE, COATED, EXTENDED RELEASE / ORAL86 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION / INTRAVENOUS1950 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET / BUCCAL109 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS900 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SUSPENSION, EXTENDED RELEASE / ORAL5400 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION / SUBCUTANEOUS47.75 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554POWDER, FOR SUSPENSION / ORAL40017 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554GRANULE, FOR SOLUTION / ORAL42596 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS2000 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, CHEWABLE / ORAL7258 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CAPSULE, DELAYED RELEASE / ORAL955 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554GRANULE / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS9.4 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET / SUBLINGUAL109 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SOLUTION / ORAL70000 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CAPSULE / ORAL3568 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554DROPS / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554ELIXIR / ORAL18000 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS1 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, DELAYED RELEASE / ORAL295.33 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554LIQUID / ORAL37500 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SUSPENSION / ORAL48209 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, EXTENDED RELEASE / ORAL284.54 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL18790 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CONCENTRATE / ORAL4800 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET / ORAL4249 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SUPPOSITORY / RECTALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554POWDER, FOR SOLUTION / ORAL38666 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554POWDER / ORAL27768 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, EMULSION / INTRAVENOUS970 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SUSPENSION/ DROPS / ORAL3750 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554WAFER / ORAL155.2 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CAPSULE, EXTENDED RELEASE / ORAL619 mgExact identifier — unii candidate
48 equally ranked IID candidates

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
3270dae5-085f-1bbb-e063-6294a90a5232f9b0bfaf-2dd6-30fc-7215-3075887eb1a92025-04-10WarningsExact identifier
spl set id: f9b0bfaf-2dd6-30fc-7215-3075887eb1a9

Reported adverse events (FAERS/openFDA)#

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