Headache - Migraine description, usages, side effects, indications, overdosage, supplying and lots more!

Headache - Migraine

Newton Laboratories, Inc.
Newton Laboratories, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Headache - Migraine

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

HEADACHE - MIGRAINE       Formulated for associated symptoms such as throbbing pain, pressure, congestion, dizziness, nausea and light sensitivity.         

DOSAGE & ADMINISTRATION SECTION             

Directions: ORAL USE ONLY - SHAKE WELL. Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) as needed or as directed by a healthcare professional.         

ACTIVE INGREDIENT SECTION

Elaps corallinus 30x, Arsenicum alb. 15x, Belladonna 15x, Bryonia 15x, Carduus benedictus 15x, Cimicifuga 15x, Coffea cruda 15x, Convallaria 15x, Crotalus horridus 15x, Digitalis 15x, Gelsemium 15x, Glonoinum 15x, Ignatia 15x, Lachesis 15x, Merc. viv. 15x, Naja 15x, Nux vom. 15x, Phosphorus 15x, Rhus toxicodendron 15x, Sanguinaria 15x, Secale 15x, Vipera berus 15x, Apis mel. 3x, Hypericum 3x, Thuja occ. 3x.                   

PURPOSE SECTION

Formulated for associated symptoms such as throbbing pain, pressure, congestion, dizziness, nausea and light sensitivity.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.           

QUESTIONS? SECTION

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256          

WARNINGS SECTION

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.            

PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant or nursing or if symptoms worsen or persist for more than a few days.       

KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.       

PACKAGE LABEL

Headache - Migraine

Elaps corallinus, Arsenicum alb., Belladonna, Bryonia, Carduus benedictus, Cimicifuga, Coffea cruda, Convallaria, Crotalus horridus, Digitalis, Gelsemium, Glonoinum, Ignatia, Lachesis, Merc. viv., Naja, Nux vom., Phosphorus, Rhus toxicodendron, Sanguinaria, Secale, Vipera berus, Apis mel., Hypericum, Thuja occ. LIQUID

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:55714-4444
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Micrurus Corallinus Venom Micrurus Corallinus Venom 30 [hp_X]
ARSENIC TRIOXIDE ARSENIC TRIOXIDE 15 [hp_X]
ATROPA BELLADONNA ATROPA BELLADONNA 15 [hp_X]
BRYONIA ALBA ROOT BRYONIA ALBA ROOT 15 [hp_X]
CENTAUREA BENEDICTA Centaurea Benedicta 15 [hp_X]
BLACK COHOSH BLACK COHOSH 15 [hp_X]
ARABICA COFFEE BEAN Arabica Coffee Bean 15 [hp_X]
CONVALLARIA MAJALIS CONVALLARIA MAJALIS 15 [hp_X]
CROTALUS HORRIDUS HORRIDUS VENOM Crotalus Horridus Horridus Venom 15 [hp_X]
Digitalis DIGITALIS 15 [hp_X]
GELSEMIUM SEMPERVIRENS ROOT GELSEMIUM SEMPERVIRENS ROOT 15 [hp_X]
nitroglycerin NITROGLYCERIN 15 [hp_X]
STRYCHNOS IGNATII SEED STRYCHNOS IGNATII SEED 15 [hp_X]
LACHESIS MUTA VENOM LACHESIS MUTA VENOM 15 [hp_X]
MERCURY Mercury 15 [hp_X]
NAJA NAJA VENOM Naja Naja Venom 15 [hp_X]
STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED 15 [hp_X]
PHOSPHORUS PHOSPHORUS 15 [hp_X]
TOXICODENDRON PUBESCENS LEAF TOXICODENDRON PUBESCENS LEAF 15 [hp_X]
SANGUINARIA CANADENSIS ROOT SANGUINARIA CANADENSIS ROOT 15 [hp_X]
CLAVICEPS PURPUREA SCLEROTIUM CLAVICEPS PURPUREA SCLEROTIUM 15 [hp_X]
Vipera Berus Venom Vipera Berus Venom 15 [hp_X]
APIS MELLIFERA APIS MELLIFERA 3 [hp_X]
Hypericum Perforatum HYPERICUM PERFORATUM 3 [hp_X]
THUJA OCCIDENTALIS LEAFY TWIG THUJA OCCIDENTALIS LEAFY TWIG 3 [hp_X]

Inactive Ingredients

Ingredient Name Strength
ALCOHOL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55714-4444-1 29.57 in 1 BOTTLE, GLASS
2 NDC:55714-4444-2 59.14 in 1 BOTTLE, GLASS

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-06-01


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