Indigestion-Gas: Homeopathic Product Information

INDIGESTION-GAS- matricaria chamomilla, sodium carbonate, iris versicolor root, ruta graveolens flowering top, taraxacum officinale, aloe, angelica sinensis root, antimony trisulfide, silver nitrate, arnica montana, arsenic trioxide, baptisia tinctoria, bismuth, bryonia alba root, cinchona officinalis bark, graphite, goldenseal, ipecac, lachesis muta venom, lycopodium clavatum spore, myrrh, phosphorus, anemone pulsatilla, ginger, strychnos nux-vomica seed and echinacea, unspecified pellet
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.

INDICATIONS & USAGE SECTION

Formulated for associated symptoms such as belching, bloating, bad breath, nausea, heartburn, flatulence and other related symptoms.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) as needed or as directed by a health professional. Sensitive persons begin with 1 pellet and gradually increase to full dose.

OTC — ACTIVE INGREDIENT SECTION

Equal parts of Chamomilla 6x, Echinacea 6x, Iris versicolor 6x, Ruta graveolens 6x, Taraxacum officinale 6x, Aloe 15x, Angelica sinensis radix 15x, Antimonium crudum 15x, Argentum nitricum 15x, Arnica montana 15x, Arsenicum album 15x, Baptisia tinctoria 15x, Bismuthum metallicum 15x, Bryonia 15x, Cinchona officinalis 15x, Graphites 15x, Hydrastis canadensis 15x, Ipecacuanha 15x, Lachesis mutus 15x, Lycopodium clavatum 15x, Myrrha 15x, Natrum carbonicum 15x, Nux vomica 15x, Phosphorus 15x, Pulsatilla 15x, Zingiber officinale 15x.

OTC — PURPOSE SECTION

Formulated for associated symptoms such as belching, bloating, bad breath, nausea, heartburn, flatulence and other related symptoms.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.

QUESTIONS SECTION

newtonlabs.net — Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 Conyers, GA 30013

WARNINGS SECTION

WARNINGS: 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.

OTC — PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding , ask a doctor before use.

OTC — KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

package label
(click image for full-size original)

INDIGESTION-GAS
chamomilla, echinacea, iris versicolor, ruta graveolens, taraxacum officinale, aloe, angelica sinensis radix, antimonium , argentum nitricum, arnica montana, arsenicum album, baptisia tinctoria, bismuthum metallicum, bryonia, cinchona officinalis, graphites, hydrastis canadensis, ipecacuanha, lachesis mutus, lycopodium clavatum, myrrha, natrum carbonicum, nux vomica, phosphorus, pulsatilla, zingiber officinale. pellet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-2466
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MATRICARIA CHAMOMILLA (MATRICARIA CHAMOMILLA) MATRICARIA CHAMOMILLA 6 [hp_X] in 1 g
SODIUM CARBONATE (CARBONATE ION) SODIUM CARBONATE 15 [hp_X] in 1 g
IRIS VERSICOLOR ROOT (IRIS VERSICOLOR ROOT) IRIS VERSICOLOR ROOT 6 [hp_X] in 1 g
RUTA GRAVEOLENS FLOWERING TOP (RUTA GRAVEOLENS FLOWERING TOP) RUTA GRAVEOLENS FLOWERING TOP 6 [hp_X] in 1 g
TARAXACUM OFFICINALE (TARAXACUM OFFICINALE) TARAXACUM OFFICINALE 6 [hp_X] in 1 g
ALOE (ALOE) ALOE 15 [hp_X] in 1 g
ANGELICA SINENSIS ROOT (ANGELICA SINENSIS ROOT) ANGELICA SINENSIS ROOT 15 [hp_X] in 1 g
ANTIMONY TRISULFIDE (ANTIMONY CATION (3+)) ANTIMONY TRISULFIDE 15 [hp_X] in 1 g
SILVER NITRATE (SILVER CATION) SILVER NITRATE 15 [hp_X] in 1 g
ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA 15 [hp_X] in 1 g
ARSENIC TRIOXIDE (ARSENIC CATION (3+)) ARSENIC TRIOXIDE 15 [hp_X] in 1 g
BAPTISIA TINCTORIA (BAPTISIA TINCTORIA) BAPTISIA TINCTORIA 15 [hp_X] in 1 g
BISMUTH (BISMUTH) BISMUTH 15 [hp_X] in 1 g
BRYONIA ALBA ROOT (BRYONIA ALBA ROOT) BRYONIA ALBA ROOT 15 [hp_X] in 1 g
CINCHONA OFFICINALIS BARK (CINCHONA OFFICINALIS BARK) CINCHONA OFFICINALIS BARK 15 [hp_X] in 1 g
GRAPHITE (GRAPHITE) GRAPHITE 15 [hp_X] in 1 g
GOLDENSEAL (GOLDENSEAL) GOLDENSEAL 15 [hp_X] in 1 g
IPECAC (IPECAC) IPECAC 15 [hp_X] in 1 g
LACHESIS MUTA VENOM (LACHESIS MUTA VENOM) LACHESIS MUTA VENOM 15 [hp_X] in 1 g
LYCOPODIUM CLAVATUM SPORE (LYCOPODIUM CLAVATUM SPORE) LYCOPODIUM CLAVATUM SPORE 15 [hp_X] in 1 g
MYRRH (MYRRH) MYRRH 15 [hp_X] in 1 g
PHOSPHORUS (PHOSPHORUS) PHOSPHORUS 15 [hp_X] in 1 g
ANEMONE PULSATILLA (ANEMONE PULSATILLA) ANEMONE PULSATILLA 15 [hp_X] in 1 g
GINGER (GINGER) GINGER 15 [hp_X] in 1 g
STRYCHNOS NUX-VOMICA SEED (STRYCHNOS NUX-VOMICA SEED) STRYCHNOS NUX-VOMICA SEED 15 [hp_X] in 1 g
ECHINACEA, UNSPECIFIED (ECHINACEA, UNSPECIFIED) ECHINACEA, UNSPECIFIED 6 [hp_X] in 1 g
Inactive Ingredients
Ingredient Name Strength
SUCROSE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55714-2466-1 28 g in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 01/01/2019
Labeler — Newton Laboratories, Inc. (788793610)
Registrant — Newton Laboratories, Inc. (788793610)
Establishment
Name Address ID/FEI Operations
Newton Laboratories, Inc. 788793610 manufacture (55714-2466)

Revised: 02/2020 Newton Laboratories, Inc.

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