Teething™

Teething™
SPL v2
SPL
SPL Set ID 8a69495f-e38c-463f-819a-f539b0efcfa9
Route
ORAL
Published
Effective Date 2016-12-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Amanita Muscaria Fruiting Body (10 [hp_X]) Atropa Belladonna Oyster Shell Calcium Carbonate, Crude Calcium Cation Matricaria Recutita Ferrosoferric Phosphate Wood Creosote Zinc
Inactive Ingredients
Water Anhydrous Citric Acid Potassium Sorbate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2012-10-22

Description

Drug Facts ​__________________________________________________________________________________________________________ HPUS active ingredients: Agaricus muscarius, Belladonna, Calcarea carbonica, Calcarea phosphorica, Chamomilla, Ferrum phosphoricum, Kreosotum, Zincum metallicum. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, 1LM, 2LM, 3LM potencies.


Medication Information

Warnings and Precautions

Warnings

  • Stop use and ask your doctor if symptoms persist or worsen.
  • If pregnant or breast-feeding, take only on advice of a healthcare professional.
Indications and Usage

Uses for temporary relief of: teething pain, swelling gums, delayed teething, low grade fever, restlessness, heavy salivation, irritability, desire to be held constantly.

Dosage and Administration

Directions

  • Initially, depress pump until primed.
  • Spray one dose directly into mouth.
  • Adults 12 and up: 3 sprays 3 times per day
  • ​Children 2-12: 2 sprays 3 times per day
  • Children 2 mo-2yr: 1 spray 3 times per day
Description

Drug Facts ​__________________________________________________________________________________________________________ HPUS active ingredients: Agaricus muscarius, Belladonna, Calcarea carbonica, Calcarea phosphorica, Chamomilla, Ferrum phosphoricum, Kreosotum, Zincum metallicum. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, 1LM, 2LM, 3LM potencies.

Section 50565-1
  • Keep out of reach of children.
Section 51727-6

Inactive Ingredients:

Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

Section 51945-4

Section 55105-1

Uses ​for temporary relief of:

  • teething pain
  • swelling gums
  • delayed teething
  • low grade fever
  • restlessness
  • heavy salivation
  • irritability
  • desire to be held constantly
Section 55106-9

Drug Facts​__________________________________________________________________________________________________________

HPUS active ingredients: Agaricus muscarius, Belladonna, Calcarea carbonica, Calcarea phosphorica, Chamomilla, Ferrum phosphoricum, Kreosotum, Zincum metallicum. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, 1LM, 2LM, 3LM potencies.

Section 60561-8

Tamper resistant for your protection . Use only if safety seal is intact. This product has not been clinically tested.


Structured Label Content

Indications and Usage (34067-9)

Uses for temporary relief of: teething pain, swelling gums, delayed teething, low grade fever, restlessness, heavy salivation, irritability, desire to be held constantly.

Dosage and Administration (34068-7)

Directions

  • Initially, depress pump until primed.
  • Spray one dose directly into mouth.
  • Adults 12 and up: 3 sprays 3 times per day
  • ​Children 2-12: 2 sprays 3 times per day
  • Children 2 mo-2yr: 1 spray 3 times per day
Warnings and Precautions (34071-1)

Warnings

  • Stop use and ask your doctor if symptoms persist or worsen.
  • If pregnant or breast-feeding, take only on advice of a healthcare professional.
Section 50565-1 (50565-1)
  • Keep out of reach of children.
Section 51727-6 (51727-6)

Inactive Ingredients:

Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Uses ​for temporary relief of:

  • teething pain
  • swelling gums
  • delayed teething
  • low grade fever
  • restlessness
  • heavy salivation
  • irritability
  • desire to be held constantly
Section 55106-9 (55106-9)

Drug Facts​__________________________________________________________________________________________________________

HPUS active ingredients: Agaricus muscarius, Belladonna, Calcarea carbonica, Calcarea phosphorica, Chamomilla, Ferrum phosphoricum, Kreosotum, Zincum metallicum. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, 1LM, 2LM, 3LM potencies.

Section 60561-8 (60561-8)

Tamper resistant for your protection . Use only if safety seal is intact. This product has not been clinically tested.


Advanced Ingredient Data


Raw Label Data

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