FDA.reportPublic FDA data

Morning Sickness - Nausea

Manufacturer
Newton Laboratories, Inc.
Effective date
2017-12-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:06:37

Label at a glance#

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

Label contents#

Full prescribing information#

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

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

OTC - QUESTIONS SECTION

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

Questions? 1.800.448.7256

INACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

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

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Chamomilla 3x, Hydrastis 3x, Iris versicolor 3x, Bismuthum metallicum 15x, Bryonia 15x, Cimicifuga 15x, Gossypium herbaceum 15x, Ipecac. 15x, Kreosotum 15x, Lycopodium 15x, Mag. carb. 15x, Nux vom. 15x, Pulsatilla 15x, Sepia 15x, Symphoricarpus racemosus 15x, Tabacum 15x, Zingiber 15x.

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.

INDICATIONS & USAGE SECTION

Morning Sickness - Nausea​: Formulated for associated symptoms such as dizziness, discomfort, indigestion, nausea, vomiting and loss of appetite.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-237855714-2378-1, 55714-2378-2, 55714-2378-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
BISMUTHU015TT5I8HACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
BLACK COHOSHK73E24S6X9ACTIB
GOSSYPIUM HERBACEUM ROOT BARKVQN1631P4CACTIB
IPECAC62I3C8233LACTIB
WOOD CREOSOTE3JYG22FD73ACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
MAGNESIUM CARBONATE0E53J927NAACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
SYMPHORICARPOS ALBUS FRUIT873JZU3ASZACTIB
TOBACCO LEAF6YR2608RSUACTIB
GINGERC5529G5JPQACTIB
MATRICARIA RECUTITAG0R4UBI2ZZACTIB
GOLDENSEALZW3Z11D0JVACTIB
IRIS VERSICOLOR ROOTX43D4L3DQCACTIB

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
b56d6034-cac1-a9e2-e053-2a95a90aebf06063a374-1839-3ae6-e053-2991aa0ae0312020-12-01WarningsExact identifier
spl set id: 6063a374-1839-3ae6-e053-2991aa0ae031

Reported adverse events (FAERS/openFDA)#

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