Digestive 4860l

Digestive 4860l
SPL v1
SPL
SPL Set ID 44e7e28b-88e5-784b-e063-6294a90a6002
Route
ORAL
Published
Effective Date 2025-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bismuth (20 [hp_X]) Antimony Trisulfide (20 [hp_M]) Silver Cation (11 [hp_X]) Arsenic Cation (3+) Baptisia Tinctoria Root 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 Podophyllum Pulsatilla Vulgaris Radish Toxicodendron Pubescens Leaf Tobacco Leaf Verbascum Thapsus Ginger Echinacea, Unspecified Juglans Regia Leaf
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2025-12-01

Description

Formulated for associated symptoms such as cramping, alternating constipation & diarrhea, indigestion, bloating and heartburn.

Purpose

Formulated for associated symptoms such as crampting, alternating constipation & diarrhea, indigestion, bloating and heartburn.


Medication Information

Purpose

Formulated for associated symptoms such as crampting, alternating constipation & diarrhea, indigestion, bloating and heartburn.

Description

Formulated for associated symptoms such as cramping, alternating constipation & diarrhea, indigestion, bloating and heartburn.

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 crampting, alternating constipation & diarrhea, indigestion, bloating and heartburn.

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 cramping, alternating constipation & diarrhea, indigestion, bloating and heartburn.

Dosage & Administration Section

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) 15 minutes before meals or as needed or as directed by a health professional.

Otc Active Ingredient Section

Equal parts of Echinacea 11x, Juglans reg 11x, Antimon crud 20x, Arg nit 20x, Arsenicum alb 20x, Baptisia 20x, Bismuth met 20x, Bryonia 20x, Chamomilla 20x, Cinchona 20x, Iris vers 20x, Kali bic 20x, Lachesis 20x, Lycopodium 20x, Mag carb 20x, Nux vom 20x, Phos 20x, Podoph pelt 20x, Pulsatilla 20x, Raphanus 20x, Rhus tox 20x, Tabacum 20x, Verbascum 20x, Zingiber 20x.

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 crampting, alternating constipation & diarrhea, indigestion, bloating and heartburn.

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 cramping, alternating constipation & diarrhea, indigestion, bloating and heartburn.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) 15 minutes before meals or as needed or as directed by a health professional.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Equal parts of Echinacea 11x, Juglans reg 11x, Antimon crud 20x, Arg nit 20x, Arsenicum alb 20x, Baptisia 20x, Bismuth met 20x, Bryonia 20x, Chamomilla 20x, Cinchona 20x, Iris vers 20x, Kali bic 20x, Lachesis 20x, Lycopodium 20x, Mag carb 20x, Nux vom 20x, Phos 20x, Podoph pelt 20x, Pulsatilla 20x, Raphanus 20x, Rhus tox 20x, Tabacum 20x, Verbascum 20x, Zingiber 20x.

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)