Fears & Nightmares™

Fears & Nightmares™
SPL v1
SPL
SPL Set ID 9e72183a-a3b8-4002-8c5e-2184f6d86395
Route
ORAL
Published
Effective Date 2013-08-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aconitum Napellus (10 [hp_X]) Aesculus Carnea Flower Garlic Gold Tribromide Oyster Shell Calcium Carbonate, Crude Matricaria Recutita Artemisia Cina Flower Helianthemum Nummularium Flower Strychnos Ignatii Seed Bromide Ion Lycopodium Clavatum Spore Mimulus Guttatus Flowering Top Paeonia Officinalis Root Phosphorus Populus Tremula Flowering Top Toxicodendron Pubescens Leaf Datura Stramonium Sulfur Viola Odorata
Inactive Ingredients
Water Citric Acid Monohydrate Potassium Sorbate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2013-08-08

Description

Drug Facts ____________________________________________________________________________________________________________ HPUS active ingredients Aconitum napellus, Aesculus carnea, flos, Allium sativum, Aurum bromatum, Calcarea carbonica, Chamomilla, Cina, Helianthemum nummularium, flos, Ignatia amara, Kali bromatum, Lycopodium clavatum, Mimulus guttatus, flos, Paeonia officinalis, Phosphorus, Populus tremula, flos, Rhus toxicodendron, Stramonium, Sulphur, Viola odorata.  ​Equal volumes of each ingredient in 10X, 30X, 100X, 1M, LM1, LM2, LM3 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 a natural aid for: frightening dreams, night terrors, restless tossing.

Dosage and Administration

Directions:

  • Initially, depress pump until primed.
  • Spray one dose directly into mouth.
  • Adults: 3 sprays 3 times per day.
  • Children 2-12 years: 2 sprays 3 times per day.
  • Use additionally as needed, up to 6 times per day.
Description

Drug Facts ____________________________________________________________________________________________________________ HPUS active ingredients Aconitum napellus, Aesculus carnea, flos, Allium sativum, Aurum bromatum, Calcarea carbonica, Chamomilla, Cina, Helianthemum nummularium, flos, Ignatia amara, Kali bromatum, Lycopodium clavatum, Mimulus guttatus, flos, Paeonia officinalis, Phosphorus, Populus tremula, flos, Rhus toxicodendron, Stramonium, Sulphur, Viola odorata.  ​Equal volumes of each ingredient in 10X, 30X, 100X, 1M, LM1, LM2, LM3 potencies.

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

Inactive ingredients: Bio-Energetically Enhanced pure water base, citric acid, potassium sorbate.

Section 51945-4

Section 55105-1

Uses a natural aid for: frightening dreams, night terrors, restless tossing.

Section 55106-9

Drug Facts

____________________________________________________________________________________________________________

HPUS active ingredients Aconitum napellus, Aesculus carnea, flos, Allium sativum, Aurum bromatum, Calcarea carbonica, Chamomilla, Cina, Helianthemum nummularium, flos, Ignatia amara, Kali bromatum, Lycopodium clavatum, Mimulus guttatus, flos, Paeonia officinalis, Phosphorus, Populus tremula, flos, Rhus toxicodendron, Stramonium, Sulphur, Viola odorata.  ​Equal volumes of each ingredient in 10X, 30X, 100X, 1M, LM1, LM2, LM3 potencies.

Section 60561-8

Tamper resistant for your protection. Use only if safety seal is intact.


Structured Label Content

Indications and Usage (34067-9)

Uses a natural aid for: frightening dreams, night terrors, restless tossing.

Dosage and Administration (34068-7)

Directions:

  • Initially, depress pump until primed.
  • Spray one dose directly into mouth.
  • Adults: 3 sprays 3 times per day.
  • Children 2-12 years: 2 sprays 3 times per day.
  • Use additionally as needed, up to 6 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 base, citric acid, potassium sorbate.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Uses a natural aid for: frightening dreams, night terrors, restless tossing.

Section 55106-9 (55106-9)

Drug Facts

____________________________________________________________________________________________________________

HPUS active ingredients Aconitum napellus, Aesculus carnea, flos, Allium sativum, Aurum bromatum, Calcarea carbonica, Chamomilla, Cina, Helianthemum nummularium, flos, Ignatia amara, Kali bromatum, Lycopodium clavatum, Mimulus guttatus, flos, Paeonia officinalis, Phosphorus, Populus tremula, flos, Rhus toxicodendron, Stramonium, Sulphur, Viola odorata.  ​Equal volumes of each ingredient in 10X, 30X, 100X, 1M, LM1, LM2, LM3 potencies.

Section 60561-8 (60561-8)

Tamper resistant for your protection. Use only if safety seal is intact.


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