Teething 1730p

Teething 1730p
SPL v3
SPL
SPL Set ID 9db4790e-28c2-2dce-e053-2a95a90ae792
Route
ORAL
Published
Effective Date 2025-11-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Valerian (6 [hp_X]) Collinsonia Canadensis Root (15 [hp_X]) Apis Mellifera Baptisia Tinctoria Root Atropa Belladonna Borate Ion Bryonia Alba Root Oyster Shell Calcium Carbonate, Crude Phosphate Ion Matricaria Chamomilla Chelidonium Majus Arabica Coffee Bean Wood Creosote Magnesium Cation Strychnos Nux-vomica Seed Podophyllum Rheum Officinale Root Scutellaria Lateriflora Whole Silicon Dioxide Turpentine Oil Ginger Citrullus Colocynthis Fruit Pulp Aconitum Napellus
Inactive Ingredients
Sucrose

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-01-01

Description

Formuated for associated symptoms such as inconsolable crying, painful and swollen gums and sleeplessness.

Indications and Usage

Formuated for associated symptoms such as inconsolable crying, painful and swollen gums and sleeplessness.

Purpose

Formuated for associated symptoms such as inconsolable crying, painful and swollen gums and sleeplessness.


Medication Information

Indications and Usage

Formuated for associated symptoms such as inconsolable crying, painful and swollen gums and sleeplessness.

Purpose

Formuated for associated symptoms such as inconsolable crying, painful and swollen gums and sleeplessness.

Description

Formuated for associated symptoms such as inconsolable crying, painful and swollen gums and sleeplessness.

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

Formuated for associated symptoms such as inconsolable crying, painful and swollen gums and sleeplessness.

Inactive Ingredient Section

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

Indications and Usage Section

Formuated for associated symptoms such as inconsolable crying, painful and swollen gums and sleeplessness.

Dosage & Administration Section

Directions: Children, ages 0 to 11, give 3 pellets by mouth (ages 12 and up, give 6 pellets) as needed or a directed by a health professional. Under age 2, crush/dissolve pellets in purified water. Sensitive person begin with 1 pellet and gradually increase to full dose.

Otc Active Ingredient Section

Equal parts of Chamomilla 6x, Valeriana officinalis 6x, Aconitum napellus 15x, Apis mellifica 15x, Baptisia tinctoria 15x, Belladonna 15x, Borax 15x, Bryonia 15x, Calcarea carbonica 15x, Calcarea phosphorica 15x, Chamomilla 15x, Chelidonium majus 15x, Coffea cruda 15x, Collinsonia canadensis 15x, Colocynthis 15x, Kreosotum 15x, Magnesia phosphorica 15x, Nux vomica 15x, Podophyllum peltatum 15x, Rheum 15x, Scutellaria lateriflora 15x, Silicea 15x, Terebinthina 15x, 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

WARNINGS: 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)

Formuated for associated symptoms such as inconsolable crying, painful and swollen gums and sleeplessness.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

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

Indications and Usage Section (INDICATIONS AND USAGE SECTION)

Formuated for associated symptoms such as inconsolable crying, painful and swollen gums and sleeplessness.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions: Children, ages 0 to 11, give 3 pellets by mouth (ages 12 and up, give 6 pellets) as needed or a directed by a health professional. Under age 2, crush/dissolve pellets in purified water. Sensitive person begin with 1 pellet and gradually increase to full dose.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Equal parts of Chamomilla 6x, Valeriana officinalis 6x, Aconitum napellus 15x, Apis mellifica 15x, Baptisia tinctoria 15x, Belladonna 15x, Borax 15x, Bryonia 15x, Calcarea carbonica 15x, Calcarea phosphorica 15x, Chamomilla 15x, Chelidonium majus 15x, Coffea cruda 15x, Collinsonia canadensis 15x, Colocynthis 15x, Kreosotum 15x, Magnesia phosphorica 15x, Nux vomica 15x, Podophyllum peltatum 15x, Rheum 15x, Scutellaria lateriflora 15x, Silicea 15x, Terebinthina 15x, 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)

WARNINGS: Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)