Indigestion - Gas description, usages, side effects, indications, overdosage, supplying and lots more!

Indigestion - Gas

Newton Laboratories, Inc.
Newton Laboratories, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Indigestion - Gas

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

INDICATIONS & USAGE SECTION

Indigestion -  Gas  Formulated for symptoms associated with digestive discomfort such as acid reflux, belching, bloating, bad breath, heartburn, nausea and flatulence.

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL.  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 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 acid reflux, belching, bloating, bad breath, heartburn, nausea and flatulence.

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

Indigestion - Gas

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 Type Human otc drug label Item Code (Source) NDC:55714-2238
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Bismuth Bismuth 15 [hp_X]
ALOE ALOE 10 [hp_X]
ANGELICA SINENSIS ROOT 10 [hp_X]
Antimony Trisulfide Antimony Trisulfide 10 [hp_X]
SILVER NITRATE SILVER CATION 10 [hp_X]
ARNICA MONTANA ARNICA MONTANA 10 [hp_X]
ARSENIC TRIOXIDE ARSENIC TRIOXIDE 10 [hp_X]
Baptisia Tinctoria Baptisia Tinctoria 10 [hp_X]
BRYONIA ALBA ROOT BRYONIA ALBA ROOT 10 [hp_X]
Cinchona Officinalis Bark Cinchona Officinalis Bark 10 [hp_X]
Graphite GRAPHITE 10 [hp_X]
GOLDENSEAL GOLDENSEAL 10 [hp_X]
Ipecac IPECAC 10 [hp_X]
LACHESIS MUTA VENOM LACHESIS MUTA VENOM 10 [hp_X]
Lycopodium Clavatum Spore LYCOPODIUM CLAVATUM SPORE 10 [hp_X]
MYRRH 10 [hp_X]
SODIUM CARBONATE 10 [hp_X]
STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED 10 [hp_X]
PHOSPHORUS PHOSPHORUS 10 [hp_X]
PULSATILLA VULGARIS PULSATILLA VULGARIS 10 [hp_X]
GINGER 10 [hp_X]
Matricaria Recutita MATRICARIA RECUTITA 3 [hp_X]
ECHINACEA, UNSPECIFIED Echinacea, Unspecified 3 [hp_X]
Iris Versicolor Root Iris Versicolor Root 3 [hp_X]
RUTA GRAVEOLENS FLOWERING TOP RUTA GRAVEOLENS FLOWERING TOP 3 [hp_X]
TARAXACUM OFFICINALE Taraxacum Officinale 3 [hp_X]

Inactive Ingredients

Ingredient Name Strength
ALCOHOL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55714-2238-1 29.57 in 1 BOTTLE, GLASS
2 NDC:55714-2238-2 59.14 in 1 BOTTLE, GLASS
3 NDC:55714-2238-0 .5 in 1 BOTTLE, GLASS

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-03-01


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