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 liquid
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 2378-Disc

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

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

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 liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55714-2378
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55714-2378-1	30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	04/17/2017	12/01/2020
2	NDC:55714-2378-2	59 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	04/17/2017	12/01/2020
3	NDC:55714-2378-0	0.5 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	04/17/2017	12/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		04/17/2017	12/01/2020

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Name	Address	ID/FEI	Business Operations
Establishment
Newton Laboratories, Inc.		788793610	manufacture(55714-2378)

Revised: 12/2020

Document Id: b56d6034-cac1-a9e2-e053-2a95a90aebf0

Set id: 6063a374-1839-3ae6-e053-2991aa0ae031

Version: 2

Effective Time: 20201201

Newton Laboratories, Inc.