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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Nausea

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) 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 met. 15x, Bryonia 15x, Cimicifuga 15x, Gossypium 15x, Ipecac. 15x, Kreosotum 15x, Lycopodium 15x, Mag. carb. 15x, Nux vom. 15x, Pulsatilla 15x, Sepia 15x, Symphoricarpus 15x, Tabacum 15x, Zingiber 15x, Chamomilla 3x, Hydrastis 3x, Iris vers. 3x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with nausea such as dizziness, discomfort, indigestion, 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

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

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:55714-8002
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:55714-8002-1	29.57 mL in 1 BOTTLE, GLASS

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		04/15/2014

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Name	Address	ID/FEI	Business Operations
Establishment
Newton Laboratories, Inc.		788793610	MANUFACTURE(55714-8002)