FDA.reportPublic FDA data

Morning Sickness

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-03-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:04:14

Label at a glance#

ProductMorning Sickness
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#

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL.  Adults, take 6 drops orally as needed or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

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, Chamomilla 3x, Hydrastis 3x, Iris versicolor 3x.

OTC - PURPOSE SECTION

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

INACTIVE INGREDIENT SECTION

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

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: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. 

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-2322-02019-11-27C16284748780-19855d018-ede6-cd31-e053-dbdaa90ab51aMorning Sickness
55714-2322-12019-11-27C16284748780-19855d018-ede6-cd31-e053-dbdaa90ab51aMorning Sickness
55714-2322-22019-11-27C16284748780-19855d018-ede6-cd31-e053-dbdaa90ab51aMorning Sickness

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2322-0Morning Sickness.5 mL in 1 BOTTLE, GLASSLIQUID.51
55714-2322-1Morning Sickness29.57 mL in 1 BOTTLE, GLASSLIQUID29.571
55714-2322-2Morning Sickness59.14 mL in 1 BOTTLE, GLASSLIQUID59.141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2322MORNING SICKNESS (BISMUTHUM METALLICUM, BRYONIA, CIMICIFUGA, GOSSYPIUM HERBACEUM, IPECAC., KREOSOTUM, LYCOPODIUM, MAG. CARB., NUX VOM., PULSATILLA, SEPIA, SYMPHORICARPUS RACEMOSUS, TABACUM, ZINGIBER, CHAMOMILLA, HYDRASTIS, IRIS VERSICOLOR) LIQUID [NEWTON LABORATORIES, INC.]1Legacy NDC, 3 package rows20130110_a6c3be5b-e834-a05a-de4f-1d79286c826a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BismuthACTIVE INGREDIENTU015TT5I8H1
Black CohoshACTIVE INGREDIENTK73E24S6X91
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B1
GingerACTIVE INGREDIENTC5529G5JPQ1
GoldensealACTIVE INGREDIENTZW3Z11D0JV1
Gossypium Herbaceum Root BarkACTIVE INGREDIENTVQN1631P4C1
IpecacACTIVE INGREDIENT62I3C8233L1
Iris Versicolor RootACTIVE INGREDIENTX43D4L3DQC1
Lycopodium Clavatum SporeACTIVE INGREDIENTC88X29Y4791
Magnesium CarbonateACTIVE INGREDIENT0E53J927NA1
Matricaria RecutitaACTIVE INGREDIENTG0R4UBI2ZZ1
Pulsatilla VulgarisACTIVE INGREDIENTI76KB35JEV1
Sepia Officinalis JuiceACTIVE INGREDIENTQDL83WN8C21
Strychnos Nux-vomica SeedACTIVE INGREDIENT269XH139191
Symphoricarpos Albus FruitACTIVE INGREDIENT873JZU3ASZ1
Tobacco LeafACTIVE INGREDIENT6YR2608RSU1
Wood CreosoteACTIVE INGREDIENT3JYG22FD731
BismuthACTIVE MOIETYU015TT5I8H1
Black CohoshACTIVE MOIETYK73E24S6X91
Bryonia Alba RootACTIVE MOIETYT7J046YI2B1
Carbonate IonACTIVE MOIETY7UJQ5OPE7D1
GingerACTIVE MOIETYC5529G5JPQ1
GoldensealACTIVE MOIETYZW3Z11D0JV1
Gossypium Herbaceum Root BarkACTIVE MOIETYVQN1631P4C1
IpecacACTIVE MOIETY62I3C8233L1
Iris Versicolor RootACTIVE MOIETYX43D4L3DQC1
Lycopodium Clavatum SporeACTIVE MOIETYC88X29Y4791
Matricaria RecutitaACTIVE MOIETYG0R4UBI2ZZ1
Pulsatilla VulgarisACTIVE MOIETYI76KB35JEV1
Sepia Officinalis JuiceACTIVE MOIETYQDL83WN8C21
Strychnos Nux-vomica SeedACTIVE MOIETY269XH139191
Symphoricarpos Albus FruitACTIVE MOIETY873JZU3ASZ1
Tobacco LeafACTIVE MOIETY6YR2608RSU1
Wood CreosoteACTIVE MOIETY3JYG22FD731
AlcoholINACTIVE INGREDIENT3K9958V90M1

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
55714-232255714-2322-1, 55714-2322-2, 55714-2322-0

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
BismuthU015TT5I8HACTIB
Bryonia Alba RootT7J046YI2BACTIB
Black CohoshK73E24S6X9ACTIB
Gossypium Herbaceum Root BarkVQN1631P4CACTIB
Ipecac62I3C8233LACTIB
Wood Creosote3JYG22FD73ACTIB
Lycopodium Clavatum SporeC88X29Y479ACTIB
Magnesium Carbonate0E53J927NAACTIM
Strychnos Nux-vomica Seed269XH13919ACTIB
Pulsatilla VulgarisI76KB35JEVACTIB
Sepia Officinalis JuiceQDL83WN8C2ACTIB
Symphoricarpos Albus Fruit873JZU3ASZACTIB
Tobacco Leaf6YR2608RSUACTIB
GingerC5529G5JPQACTIB
Matricaria RecutitaG0R4UBI2ZZACTIB
GoldensealZW3Z11D0JVACTIB
Iris Versicolor RootX43D4L3DQCACTIB
Alcohol3K9958V90MIACT

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 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 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
4e12d2ba-c37e-88c7-4b6f-ab61cc71e7b2a6c3be5b-e834-a05a-de4f-1d79286c826a2011-03-01WarningsExact identifier
spl id: 4e12d2ba-c37e-88c7-4b6f-ab61cc71e7b2
spl set id: a6c3be5b-e834-a05a-de4f-1d79286c826a

Reported adverse events (FAERS/openFDA)#

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