Tummy Upset

Tummy Upset
SPL v1
SPL
SPL Set ID 8dc30cb6-492a-c7d3-f3e7-40465abd4687
Route
ORAL
Published
Effective Date 2012-09-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bismuth (15 [hp_X]) Aloe (10 [hp_X]) Angelica Sinensis Root (3 [hp_X]) Antimony Trisulfide Silver Cation Arnica Montana Arsenic Cation (3+) Baptisia Tinctoria Bryonia Alba Root Cinchona Officinalis Bark Graphite Goldenseal Ipecac Lachesis Muta Venom Lycopodium Clavatum Spore Myrrh Carbonate Ion Strychnos Nux-vomica Seed Phosphorus Pulsatilla Vulgaris Ginger Matricaria Recutita Echinacea, Unspecified Iris Versicolor Root Ruta Graveolens Flowering Top Taraxacum Officinale
Inactive Ingredients
Sucrose

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2011-03-01

Description

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

Purpose

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


Medication Information

Purpose

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

Description

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

Package Label

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.  

Questions Section

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012

Questions?  1.800.448.7256

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: Gluten-free, non-GMO, beet-derived sucrose pellets.

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

 Directions:  Children, ages 0 to 11, give 3 pellets orally (ages 12 and up, give 6 pellets) as needed or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water.  Sensitive persons begin with 1 pellet 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 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.


Structured Label Content

Package Label (PACKAGE LABEL)

Warnings Section (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.  

Questions Section (QUESTIONS SECTION)

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012

Questions?  1.800.448.7256

Otc Purpose Section (OTC - PURPOSE SECTION)

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

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.

Indications & Usage Section (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 (DOSAGE & ADMINISTRATION SECTION)

 Directions:  Children, ages 0 to 11, give 3 pellets orally (ages 12 and up, give 6 pellets) as needed or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water.  Sensitive persons begin with 1 pellet and gradually increase to full dose.

Otc Active Ingredient Section (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 Pregnancy Or Breast Feeding Section (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 (OTC - KEEP OUT OF REACH OF CHILDREN SECTION)

Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

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