Para-si 4859l

Para-si 4859l
SPL v1
SPL
SPL Set ID 27d5997b-1cae-41c2-e063-6394a90ac74a
Route
ORAL
Published
Effective Date 2024-11-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Artemisia Abrotanum Flowering Top (20 [hp_X]) Horse Chestnut (11 [hp_X]) Garlic Arsenic Cation (3+) Artemisia Vulgaris Root Baptisia Tinctoria Root Artemisia Cina Pre-flowering Top Copper Dryopteris Filix-mas Root Punica Granatum Root Bark Ipecac Lachesis Muta Venom Lycopodium Clavatum Spore Mercury Naphthalene Chloride Ion Strychnos Nux-vomica Seed Anemone Pulsatilla Krameria Lappacea Root Ruta Graveolens Flowering Top Schoenocaulon Officinale Seed Santonin Silicon Dioxide Spigelia Anthelmia Ginger Turpentine Oil Teucrium Marum Thymol Juglans Regia Leaf
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2024-11-26
Description

Formulated for symptoms such as bloating, fatigue, itching, nausea, teeth grinding, increased appetite, cramping and sluggish elimination.

Purpose

Formulated for symptoms such as bloating, fatigue, itching, nausea, teeth grinding, increased appetite, cramping and sluggish elimination.

Medication Information

Purpose

Formulated for symptoms such as bloating, fatigue, itching, nausea, teeth grinding, increased appetite, cramping and sluggish elimination.

Description

Formulated for symptoms such as bloating, fatigue, itching, nausea, teeth grinding, increased appetite, cramping and sluggish elimination.

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 symptoms such as bloating, fatigue, itching, nausea, teeth grinding, increased appetite, cramping and sluggish elimination.

Inactive Ingredient Section

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

Indications & Usage Section

Formulated for symptoms such as bloating, fatigue, itching, nausea, teeth grinding, increased appetite, cramping and sluggish elimination.

Dosage & Administration Section

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) one to four times daily or as directed by a health professional. Warning: For severe parasitic infestation or prolonged symptoms, consult a licensed health professional.

Otc Active Ingredient Section

Equal parts of Juglans reg 11x, Abrotanum 20x, Aesculus hipp 20x, Allium sat 20x, Arsenicum alb 20x, Artemisia 20x, Baptisia 20x, Cina 20x, Cuprum met 20x, Filix mas 20x, Granatum 20x, Ipecac 20x, Lachesis 20x, Lycopodium 20x, Merc viv 20x, Naphthalinum 20x, Nat mur 20x, Nux vom 20x, Pulsatilla 20x, Ratanhia 20x, Ruta 20x, Sabadilla 20x, Santoninum 20x, Silicea 20x, Spigelia anth 20x, Terebinthina 20x, Teucrium mar 20x, Thymolum 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 symptoms such as bloating, fatigue, itching, nausea, teeth grinding, increased appetite, cramping and sluggish elimination.

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 symptoms such as bloating, fatigue, itching, nausea, teeth grinding, increased appetite, cramping and sluggish elimination.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) one to four times daily or as directed by a health professional. Warning: For severe parasitic infestation or prolonged symptoms, consult a licensed health professional.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Equal parts of Juglans reg 11x, Abrotanum 20x, Aesculus hipp 20x, Allium sat 20x, Arsenicum alb 20x, Artemisia 20x, Baptisia 20x, Cina 20x, Cuprum met 20x, Filix mas 20x, Granatum 20x, Ipecac 20x, Lachesis 20x, Lycopodium 20x, Merc viv 20x, Naphthalinum 20x, Nat mur 20x, Nux vom 20x, Pulsatilla 20x, Ratanhia 20x, Ruta 20x, Sabadilla 20x, Santoninum 20x, Silicea 20x, Spigelia anth 20x, Terebinthina 20x, Teucrium mar 20x, Thymolum 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)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:11:37.750483 · Updated: 2026-03-14T23:17:02.790528