Morning Sickness - Nausea-2

Morning Sickness - Nausea by

Drug Labeling and Warnings

Morning Sickness - Nausea by is a Homeopathic medication manufactured, distributed, or labeled by Newton Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MORNING SICKNESS - NAUSEA- bismuthum metallicum, bryonia, cimicifuga, gossypium herbaceum, ipecac., kreosotum, lycopodium, mag. carb., nux vom., pulsatilla, sepia, symphoricarpus racemosus, tabacum, zingiber, chamomilla, hydrastis, iris versicolor pellet 
Newton Laboratories, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Morning Sickness - Nausea-2

OTC - Purpose Section

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

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, ​ask a doctor before use.

WARNINGS SECTION

Warning:​Keep out of reach of children. Do not use ​if tamper-evident seal is missing or broken. If symptoms worsen or persist for more than a couple of days, consult a doctor. If ​pregnant or breast-feeding,​ ask a doctor before use.

QUESTIONS SECTION

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

Questions? 1.800.448.7256

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.

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 15.

DOSAGE & ADMINISTRATION SECTION

Directions: Adults, take 6 pellets by mouth as needed or as directed by a health professional. Sensitive persons begin with 1 pellet 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

MORNING SICKNESS - NAUSEA 
bismuthum metallicum, bryonia, cimicifuga, gossypium herbaceum, ipecac., kreosotum, lycopodium, mag. carb., nux vom., pulsatilla, sepia, symphoricarpus racemosus, tabacum, zingiber, chamomilla, hydrastis, iris versicolor pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55714-2379
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH (UNII: U015TT5I8H) (BISMUTH - UNII:U015TT5I8H)	BISMUTH	15 [hp_X]  in 1 g
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	15 [hp_X]  in 1 g
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9)	BLACK COHOSH	15 [hp_X]  in 1 g
GOSSYPIUM HERBACEUM ROOT BARK (UNII: VQN1631P4C) (GOSSYPIUM HERBACEUM ROOT BARK - UNII:VQN1631P4C)	GOSSYPIUM HERBACEUM ROOT BARK	15 [hp_X]  in 1 g
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L)	IPECAC	15 [hp_X]  in 1 g
WOOD CREOSOTE (UNII: 3JYG22FD73) (WOOD CREOSOTE - UNII:3JYG22FD73)	WOOD CREOSOTE	15 [hp_X]  in 1 g
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	15 [hp_X]  in 1 g
MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D)	MAGNESIUM CARBONATE	15 [hp_X]  in 1 g
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	15 [hp_X]  in 1 g
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	15 [hp_X]  in 1 g
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	15 [hp_X]  in 1 g
SYMPHORICARPOS ALBUS FRUIT (UNII: 873JZU3ASZ) (SYMPHORICARPOS ALBUS FRUIT - UNII:873JZU3ASZ)	SYMPHORICARPOS ALBUS FRUIT	15 [hp_X]  in 1 g
TOBACCO LEAF (UNII: 6YR2608RSU) (TOBACCO LEAF - UNII:6YR2608RSU)	TOBACCO LEAF	15 [hp_X]  in 1 g
GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ)	GINGER	15 [hp_X]  in 1 g
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	3 [hp_X]  in 1 g
IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC)	IRIS VERSICOLOR ROOT	3 [hp_X]  in 1 g
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	3 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55714-2379-1	28 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	04/17/2017	01/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/17/2017	01/01/2020

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Establishment
Name	Address	ID/FEI	Business Operations
Newton Laboratories, Inc.		788793610	manufacture(55714-2379)

Revised: 2/2020

Document Id: 9deef474-9aeb-7092-e053-2995a90a0691

34390-5

Set id: 60645c63-bb64-49ea-e053-2a91aa0aeea6

Version: 2

Effective Time: 20200206

 

Newton Laboratories, Inc.