Para-si 2593l

Para-si 2593l
SPL v2
SPL
SPL Set ID 27d41602-9dcb-eaa8-e063-6394a90a7cfa
Route
ORAL
Published
Effective Date 2024-11-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Teucrium Marum (15 [hp_X]) Artemisia Vulgaris Root (6 [hp_X]) Dryopteris Filix-mas Root Juglans Regia Leaf Spigelia Anthelmia Thymol Garlic Arsenic Cation (3+) Baptisia Tinctoria Root Artemisia Cina Pre-flowering Top Copper Punica Granatum Root Bark Ipecac Lachesis Muta Venom Lycopodium Clavatum Spore Mercury Artemisia Abrotanum Flowering Top Naphthalene Sodium Cation Strychnos Nux-vomica Seed Anemone Pulsatilla Krameria Lappacea Root Ruta Graveolens Flowering Top Schoenocaulon Officinale Seed Santonin Horse Chestnut Ginger Silicon Dioxide Turpentine Oil
Inactive Ingredients
Alcohol Water

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, sluggish elimination and other related symptoms.

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, sluggish elimination and other related symptoms.

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, sluggish elimination and other related symptoms.

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. Sensitive persons begin with 1 drop and gradually increase to full dose. Warning: For severe parasitic infestation or prolonged symptoms, consult a licensed health professional.

Otc Active Ingredient Section

Equal parts of Juglans reg 6x, Abrotanum 15x, Aesculus hipp 15x, Allium sat 15x, Arsenicum alb 15x, Artemisia 15x, Baptisia 15x, Cina 15x, Cuprum met 15x, Filix mas 15x, Granatum 15x, Ipecac 15x, Lachesis 15x, Lycopodium 15x, Mercurius viv 15x, Naphthalinum 15x, Nat mur 15x, Nux vom 15x, Pulsatilla 15x, Ratanhia 15x, Ruta 15x, Sabadilla 15x, Santoninum 15x, Silicea 15x, Spigelia anth 15x, Terebinthina 15x, Teucrium mar 15x, Thymolum 15x, Zingiber 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 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, sluggish elimination and other related symptoms.

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. Sensitive persons begin with 1 drop and gradually increase to full dose. 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 6x, Abrotanum 15x, Aesculus hipp 15x, Allium sat 15x, Arsenicum alb 15x, Artemisia 15x, Baptisia 15x, Cina 15x, Cuprum met 15x, Filix mas 15x, Granatum 15x, Ipecac 15x, Lachesis 15x, Lycopodium 15x, Mercurius viv 15x, Naphthalinum 15x, Nat mur 15x, Nux vom 15x, Pulsatilla 15x, Ratanhia 15x, Ruta 15x, Sabadilla 15x, Santoninum 15x, Silicea 15x, Spigelia anth 15x, Terebinthina 15x, Teucrium mar 15x, Thymolum 15x, Zingiber 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)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:11:37.746336 · Updated: 2026-03-14T23:17:02.790528