Baby Teething

SPL v1

SPL

SPL Set ID fbd2b2b3-a1e8-4f62-848e-e05b89b8ee47

Route

ORAL

Published

Effective Date 2018-03-05

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Amanita Muscaria Fruiting Body (30 [hp_X]) Oyster Shell Calcium Carbonate, Crude Fluoride Ion Calcium Cation Matricaria Chamomilla Ferrosoferric Phosphate Calcium Sulfide Magnesium Cation Phytolacca Americana Root Podophyllum Rheum Officinale Root Zinc

Inactive Ingredients

Water Carya Ovata Bark Citrus Bioflavonoids Lonicera Japonica Flower Polyepsilon-lysine (4000 Mw) Rebaudioside A

Identifiers & Packaging

Marketing Status

UNAPPROVED HOMEOPATHIC Active Since 2018-03-05

Description

Agaicus muscarius, Calcarea carbonica, Calcarea fluorica, Calcarea phosphorica, Chamomilla, Ferrum phosphoricum, Hepar sulphuris calcareum, Magnesia phosphorica, Phytolacca decandra, Podophyllum peltatum, Rheum, Zincum metallicum Equal volumes of each in 30X, 60X, and 1LM potencies.

Purpose

HPUS Ingredient: Purpose: Agaicus muscarius...............................irritated gums Calcarea carbonica...............................sleeplessness, difficult, delayed teething Calcarea fluorica..................................toothache, vomiting in infants, supports dental development Calcarea phosphorica............................discomforts from teething Chamomilla..........................................desire to be held constantly Ferrum phosphoricum............................fever-like disturbaces Hepar sulphuris calcareum......................overly sensitive Magnesia phosphorica............................complaints of teething Phytolacca decandra...............................excess saliva, teething children, clenched teeth Podophyllum peltatum............................drooling, difficult dentition, fussiness, restlessness Rheum.................................................increased saliva, difficult teething, restlessness, irritability Zincum metallicum.................................difficult teething, irritability

Medication Information

Purpose

HPUS Ingredient: Purpose:

Agaicus muscarius...............................irritated gums

Calcarea carbonica...............................sleeplessness, difficult, delayed teething

Calcarea fluorica..................................toothache, vomiting in infants, supports dental development

Calcarea phosphorica............................discomforts from teething

Chamomilla..........................................desire to be held constantly

Ferrum phosphoricum............................fever-like disturbaces

Hepar sulphuris calcareum......................overly sensitive

Magnesia phosphorica............................complaints of teething

Phytolacca decandra...............................excess saliva, teething children, clenched teeth

Podophyllum peltatum............................drooling, difficult dentition, fussiness, restlessness

Rheum.................................................increased saliva, difficult teething, restlessness, irritability

Zincum metallicum.................................difficult teething, irritability

Description

Uses

for temporary relief of:

tething pain
irritated gums
delayed teething
fever-like disturbances
restlessness
heavy salivation and drooling
irritability
desire to be held constantly

Section 50565-1

Keep out of reach of children

Section 51945-4

Warnings

Stop use and ask a doctor, if symptoms persist or worsen.
If pregnant or breast-feeding, ask a healthcare professional before use.

directions

Initially, depress pump until primed.
Spray one dose directly into mouth

Under 3 months: Consult a licensed healthcare professional before using

3 months to 2 years: 1 spray every 15 minutes. up to 4 doses, then hourly until relieved

2 to 6 years: 2 sprays every 15 minutes, up to 4 doses, then hourly until relieved

Inactive Ingredients

Bio-Energetically Enhanced pure water, Carya ovata bark extract (hickory), citrus extract, Lonicer japonica (honeysuckle), polylysine (natural ferment), steviol glycosides (stevia)

other Information

This product is intended to compliment, not replace, standard medical care.
Tamper resistant for your protection. Use only if safety seal is intact.

Hpus Active Ingredients

Equal volumes of each in 30X, 60X, and 1LM potencies.

Structured Label Content

Uses

for temporary relief of:

tething pain
irritated gums
delayed teething
fever-like disturbances
restlessness
heavy salivation and drooling
irritability
desire to be held constantly

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51945-4 (51945-4)