FDA.reportPublic FDA data

Morning Sickness-Nausea

Manufacturer
Newton Laboratories, Inc.
Effective date
2025-02-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:31:52

Label at a glance#

ProductMorning Sickness-Nausea
Active ingredientIRIS VERSICOLOR ROOT, BISMUTH, BRYONIA ALBA ROOT, BLACK COHOSH, GOSSYPIUM HERBACEUM ROOT BARK, IPECAC, WOOD CREOSOTE, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM CARBONATE, STRYCHNOS NUX-VOMICA SEED, MATRICARIA CHAMOMILLA, GINGER, SEPIA OFFICINALIS JUICE, SYMPHORICARPOS ALBUS FRUIT, TOBACCO LEAF, GOLDENSEAL, ANEMONE PULSATILLA
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for associated symptoms such as dizziness, discomfort, indigestion, nausea, vomiting and loss of appetite.

DOSAGE & ADMINISTRATION SECTION

Directions: Adults, take 6 drops by mouth as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Chamomilla 6x, Hydrastis canadensis 6x, Iris versicolor 6x, Bismuthum metallicum 15x, Bryonia 15x, Cimicifuga racemosa 15x, Gossypium herbaceum 15x, Ipecacuanha 15x, Kreosotum 15x, Lycopodium clavatum 15x, Magnesia carbonica 15x, Nux vomica 15x, Pulsatilla 15x, Sepia 15x, Symphoricarpus racemosus 15x, Tabacum 15x, Zingiber officinale 15x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as irregularity, cramping, bloating, headache, cravings, emotional upsets and mood swings.

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: 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2483-1Morning Sickness-Nausea30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2483MORNING SICKNESS-NAUSEA (CHAMOMILLA, HYDRASTIS CANADENSIS, IRIS VERSICOLOR, BISMUTHUM METALLICUM, BRYONIA, CIMICIFUGA RACEMOSA, GOSSYPIUM HERBACEUM, IPECACUANHA, KREOSOTUM, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, NUX VOMICA, PULSATILLA, SEPIA, SYMPHORICARPUS RACEMOSUS, TABACUM, ZINGIBER OFFICINALE.) LIQUID [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20250210_9c4a6bf8-5f48-96a8-e053-2a95a90a9757.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-248355714-2483-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
IRIS VERSICOLOR ROOTX43D4L3DQCACTIB
BISMUTHU015TT5I8HACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
BLACK COHOSHK73E24S6X9ACTIB
GOSSYPIUM HERBACEUM ROOT BARKVQN1631P4CACTIB
IPECAC62I3C8233LACTIB
WOOD CREOSOTE3JYG22FD73ACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
MAGNESIUM CARBONATE0E53J927NAACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
MATRICARIA CHAMOMILLAG0R4UBI2ZZACTIB
GINGERC5529G5JPQACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
SYMPHORICARPOS ALBUS FRUIT873JZU3ASZACTIB
TOBACCO LEAF6YR2608RSUACTIB
GOLDENSEALZW3Z11D0JVACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB

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
Morning Sickness-NauseaCHAMOMILLA, HYDRASTIS CANADENSIS, IRIS VERSICOLOR, BISMUTHUM METALLICUM, BRYONIA, CIMICIFUGA RACEMOSA, GOSSYPIUM HERBACEUM, IPECACUANHA, KREOSOTUM, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, NUX VOMICA, PULSATILLA, SEPIA, SYMPHORICARPUS RACEMOSUS, TABACUM, ZINGIBER OFFICINALE.Newton Laboratories, Inc.9c4a6bf8-5f48-96a8-e053-2a95a90a97572025-02-07WarningsExact identifier
ndc (package): 55714-2483-1
ndc (product): 55714-2483
ndc11 (package): 55714248301
spl id: 2d92fdc4-f628-5432-e063-6394a90a7092
spl set id: 9c4a6bf8-5f48-96a8-e053-2a95a90a9757

Reported adverse events (FAERS/openFDA)#

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