Headache Freee™

Headache Freee™
SPL v2
SPL
SPL Set ID 4963854f-37ab-4250-b275-3e5f30aa5b2c
Route
ORAL
Published
Effective Date 2018-02-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Atropa Belladonna (10 [hp_X]) Bryonia Alba Root Capsicum Quinine Arabica Coffee Bean Gelsemium Sempervirens Root Nitroglycerin Strychnos Ignatii Seed Dichromate Ion Lycopodium Clavatum Spore Chloride Ion Strychnos Nux-vomica Seed Sanguinaria Canadensis Root Spigelia Anthelmia Sulfur
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 2018-02-14

Description

Drug Facts ​__________________________________________________________________________________________________________ HPUS active ingredients: ​Belladonna, Bryonia, Capsicum, Chininum arsenicosum, Coffea cruda, Gelsemium, Glonoinum, Ignatia, Kali bic, Lycopodium, Nat mur, Nux vom, Sanguinaria, Spigelia anth, Sulphur. Equal volumes of each ingredient in 10X, 30X, 100X, 1LM, 2LM, 3LM, 5LM 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 headache pain: throbbing, splitting, tight, dull, sick, bursting, sinus, congestive, migraine, occipital.

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-2 yr: 1 spray 3 times per day.
Description

Drug Facts ​__________________________________________________________________________________________________________ HPUS active ingredients: ​Belladonna, Bryonia, Capsicum, Chininum arsenicosum, Coffea cruda, Gelsemium, Glonoinum, Ignatia, Kali bic, Lycopodium, Nat mur, Nux vom, Sanguinaria, Spigelia anth, Sulphur. Equal volumes of each ingredient in 10X, 30X, 100X, 1LM, 2LM, 3LM, 5LM potencies.

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

Inactive Ingredients:

Bio-Energetically Enhanced™ pure water, Carya ovata bark extract, citrus extract, Lonicera japonica (honeysuckle), polylysine, steviol glycosides.

Section 51945-4

Section 55105-1

Uses ​for temporary relief of headache pain:

  • throbbing
  • splitting
  • tight
  • dull
  • sick
  • bursting
  • sinus
  • congestive
  • migraine
  • occipital
Section 55106-9

Drug Facts​__________________________________________________________________________________________________________

HPUS active ingredients: ​Belladonna, Bryonia, Capsicum, Chininum arsenicosum, Coffea cruda, Gelsemium, Glonoinum, Ignatia, Kali bic, Lycopodium, Nat mur, Nux vom, Sanguinaria, Spigelia anth, Sulphur.

Equal volumes of each ingredient in 10X, 30X, 100X, 1LM, 2LM, 3LM, 5LM 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 headache pain: throbbing, splitting, tight, dull, sick, bursting, sinus, congestive, migraine, occipital.

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-2 yr: 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, Carya ovata bark extract, citrus extract, Lonicera japonica (honeysuckle), polylysine, steviol glycosides.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Uses ​for temporary relief of headache pain:

  • throbbing
  • splitting
  • tight
  • dull
  • sick
  • bursting
  • sinus
  • congestive
  • migraine
  • occipital
Section 55106-9 (55106-9)

Drug Facts​__________________________________________________________________________________________________________

HPUS active ingredients: ​Belladonna, Bryonia, Capsicum, Chininum arsenicosum, Coffea cruda, Gelsemium, Glonoinum, Ignatia, Kali bic, Lycopodium, Nat mur, Nux vom, Sanguinaria, Spigelia anth, Sulphur.

Equal volumes of each ingredient in 10X, 30X, 100X, 1LM, 2LM, 3LM, 5LM 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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