TUMMY UPSET - bismuthum metallicum, aloe, angelica sinensis radix, antimon. crud., arg. nit., arnica, arsenicum alb., baptisia, bryonia, cinchona, graphites, hydrastis, ipecac., lachesis, lycopodium, myrrha, nat. carb., nux vom., phosphorus, pulsatilla, zingiber, chamomilla, echinacea, iris versicolor, ruta, taraxacum 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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Tummy Upset

INDICATIONS & USAGE SECTION

Tummy Upset  Formulated for symptoms associated with digestive discomfort such as nausea, "spitting up", vomiting, cramping, pain and gas.

DOSAGE & ADMINISTRATION SECTION

ORAL USE ONLY - SHAKE WELL.  Children, ages 0 to 11, give 3 drops orally (ages 12 and up, give 6 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 metallicum 15x, Aloe 10x, Angelica sinensis radix 10x, Antimon. crud. 10x, Arg. nit. 10x, Arnica 10x, Arsenicum alb. 10x, Baptisia 10x, Bryonia 10x, Cinchona 10x, Graphites 10x, Hydrastis 10x, Ipecac. 10x, Lachesis 10x, Lycopodium 10x, Myrrha 10x, Nat. carb. 10x, Nux vom. 10x, Phosphorus 10x, Pulsatilla 10x, Zingiber 10x, Chamomilla 3x, Echinacea 3x, Iris versicolor 3x, Ruta 3x, Taraxacum 3x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with digestive discomfort such as nausea,"spitting up", vomiting, cramping, pain and gas.

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

package label

TUMMY UPSET  
bismuthum metallicum, aloe, angelica sinensis radix, antimon. crud., arg. nit., arnica, arsenicum alb., baptisia, bryonia, cinchona, graphites, hydrastis, ipecac., lachesis, lycopodium, myrrha, nat. carb., nux vom., phosphorus, pulsatilla, zingiber, chamomilla, echinacea, iris versicolor, ruta, taraxacum liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-1508
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bismuth (UNII: U015TT5I8H) (Bismuth - UNII:U015TT5I8H) Bismuth15 [hp_X]  in 1 mL
Aloe (UNII: V5VD430YW9) (Aloe - UNII:V5VD430YW9) Aloe10 [hp_X]  in 1 mL
Angelica Sinensis Root (UNII: B66F4574UG) (Angelica Sinensis Root - UNII:B66F4574UG) Angelica Sinensis Root10 [hp_X]  in 1 mL
Antimony Trisulfide (UNII: F79059A38U) (Antimony Trisulfide - UNII:F79059A38U) Antimony Trisulfide10 [hp_X]  in 1 mL
Silver Nitrate (UNII: 95IT3W8JZE) (Silver Cation - UNII:57N7B0K90A) Silver Nitrate10 [hp_X]  in 1 mL
Arnica Montana (UNII: O80TY208ZW) (Arnica Montana - UNII:O80TY208ZW) Arnica Montana10 [hp_X]  in 1 mL
Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide10 [hp_X]  in 1 mL
Baptisia Tinctoria (UNII: 5K1UO2888Y) (Baptisia Tinctoria - UNII:5K1UO2888Y) Baptisia Tinctoria10 [hp_X]  in 1 mL
Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root10 [hp_X]  in 1 mL
Cinchona Officinalis Bark (UNII: S003A158SB) (Cinchona Officinalis Bark - UNII:S003A158SB) Cinchona Officinalis Bark10 [hp_X]  in 1 mL
Graphite (UNII: 4QQN74LH4O) (Graphite - UNII:4QQN74LH4O) Graphite10 [hp_X]  in 1 mL
Goldenseal (UNII: ZW3Z11D0JV) (Goldenseal - UNII:ZW3Z11D0JV) Goldenseal10 [hp_X]  in 1 mL
Ipecac (UNII: 62I3C8233L) (Ipecac - UNII:62I3C8233L) Ipecac10 [hp_X]  in 1 mL
Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I) Lachesis Muta Venom10 [hp_X]  in 1 mL
Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore10 [hp_X]  in 1 mL
Myrrh (UNII: JC71GJ1F3L) (Myrrh - UNII:JC71GJ1F3L) Myrrh10 [hp_X]  in 1 mL
Sodium Carbonate (UNII: 45P3261C7T) (Carbonate Ion - UNII:7UJQ5OPE7D) Sodium Carbonate10 [hp_X]  in 1 mL
Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed10 [hp_X]  in 1 mL
Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus10 [hp_X]  in 1 mL
Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris10 [hp_X]  in 1 mL
Ginger (UNII: C5529G5JPQ) (Ginger - UNII:C5529G5JPQ) Ginger10 [hp_X]  in 1 mL
Matricaria Recutita (UNII: G0R4UBI2ZZ) (Matricaria Recutita - UNII:G0R4UBI2ZZ) Matricaria Recutita3 [hp_X]  in 1 mL
Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified3 [hp_X]  in 1 mL
Iris Versicolor Root (UNII: X43D4L3DQC) (Iris Versicolor Root - UNII:X43D4L3DQC) Iris Versicolor Root3 [hp_X]  in 1 mL
Ruta Graveolens Flowering Top (UNII: N94C2U587S) (Ruta Graveolens Flowering Top - UNII:N94C2U587S) Ruta Graveolens Flowering Top3 [hp_X]  in 1 mL
Taraxacum Officinale (UNII: 39981FM375) (Taraxacum Officinale - UNII:39981FM375) Taraxacum Officinale3 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-1508-129.57 mL in 1 BOTTLE, GLASS
2NDC:55714-1508-259.14 mL in 1 BOTTLE, GLASS
3NDC:55714-1508-0.5 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/01/2011
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610MANUFACTURE(55714-1508)

Revised: 3/2011
Document Id: 13bd63e7-32cd-b272-1e7c-3fe49c04fa45
Set id: 093124a1-cbc0-aa01-8f0d-192090407642
Version: 1
Effective Time: 20110301
 
Newton Laboratories, Inc.