Bowel 1534l

Bowel 1534l
SPL v2
SPL
SPL Set ID 9d60d399-6f63-5842-e053-2995a90a7cf7
Route
ORAL
Published
Effective Date 2019-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ginger (15 [hp_X]) Echinacea, Unspecified (6 [hp_X]) Arsenic Cation (3+) Antimony Cation (3+) Silver Cation Bismuth Bryonia Alba Root Matricaria Chamomilla Cinchona Officinalis Bark Iris Versicolor Root Dichromate Ion Lachesis Muta Venom Lycopodium Clavatum Spore Carbonate Ion Strychnos Nux-vomica Seed Phosphorus Toxicodendron Pubescens Leaf Podophyllum Anemone Pulsatilla Radish Tobacco Leaf Baptisia Tinctoria Root Juglans Regia Leaf Verbascum Thapsus
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-01-01

Description

Formulated for associated symptoms such as vomiting, burning, bloating, gas, nausea, cramping and pressure.

Purpose

Formulated for associated symptoms such as vomiting, burning, bloating, gas, nausea, cramping and pressure.


Medication Information

Purpose

Formulated for associated symptoms such as vomiting, burning, bloating, gas, nausea, cramping and pressure.

Description

Formulated for associated symptoms such as vomiting, burning, bloating, gas, nausea, cramping and pressure.

Package Label

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.

Questions Section

newtonlabs.net – Questions? 800.448.7256

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

Otc Purpose Section

Formulated for associated symptoms such as vomiting, burning, bloating, gas, nausea, cramping and pressure.

Inactive Ingredient Section

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

Indications & Usage Section

Formulated for associated symptoms such as vomiting, burning, bloating, gas, nausea, cramping and pressure.

Dosage & Administration Section

Directions: Children, ages 0 to 11, give 3 drops by mouth (ages 12 and up, give 6 drops) 15 minutes before meals, as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc Active Ingredient Section

Equal parts of Echinacea 6x, Juglans regia 6x, Antimonium crudum 15x, Argentum nitricum 15x, Arsenicum album 15x, Baptisia tinctoria 15x, Bismuthum metallicum 15x, Bryonia 15x, Chamomilla 15x, Cinchona officinalis 15x, Iris versicolor 15x, Kali bichromicum 15x, Lachesis mutus 15x, Lycopodium clavatum 15x, Magnesia carbonica 15x, Nux vomica 15x, Phosphorus 15x, Podophyllum peltatum 15x, Pulsatilla 15x, Raphanus sativus 15x, Rhus toxicodendron 15x, Tabacum 15x, Verbascum thapsus15x, Zingiber officinale 15x

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.


Structured Label Content

Package Label (PACKAGE LABEL)

Warnings Section (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.

Questions Section (QUESTIONS SECTION)

newtonlabs.net – Questions? 800.448.7256

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

Otc Purpose Section (OTC - PURPOSE SECTION)

Formulated for associated symptoms such as vomiting, burning, bloating, gas, nausea, cramping and pressure.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Formulated for associated symptoms such as vomiting, burning, bloating, gas, nausea, cramping and pressure.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions: Children, ages 0 to 11, give 3 drops by mouth (ages 12 and up, give 6 drops) 15 minutes before meals, as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Equal parts of Echinacea 6x, Juglans regia 6x, Antimonium crudum 15x, Argentum nitricum 15x, Arsenicum album 15x, Baptisia tinctoria 15x, Bismuthum metallicum 15x, Bryonia 15x, Chamomilla 15x, Cinchona officinalis 15x, Iris versicolor 15x, Kali bichromicum 15x, Lachesis mutus 15x, Lycopodium clavatum 15x, Magnesia carbonica 15x, Nux vomica 15x, Phosphorus 15x, Podophyllum peltatum 15x, Pulsatilla 15x, Raphanus sativus 15x, Rhus toxicodendron 15x, Tabacum 15x, Verbascum thapsus15x, Zingiber officinale 15x

Otc Pregnancy Or Breast Feeding Section (OTC - PREGNANCY OR BREAST FEEDING SECTION)

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

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

All Sections (JSON)