Hemorrhoids description, usages, side effects, indications, overdosage, supplying and lots more!

Hemorrhoids

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
Hemorrhoids

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

INDICATIONS & USAGE SECTION

Hemorrhoids  Formulated for symptoms associated with hemorrhoids such as difficult elimination, itching, inflammation, burning pain and pressure.

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) one to four times daily or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Elaps corallinus 30x, Aesculus hipp.15x, Aloe 15x, Arsenicum alb. 15x, Bryonia 15x, Calc. fluor. 15x, Capsicum 15x, Collinsonia 15x, Crotalus horridus 15x, Hamamelis 15x, Hydrofluoricum acidum 15x, Hypericum 15x, Lachesis 15x, Lycopodium 15x, Millefolium 15x, Naja 15x, Nux vom. 15x, Paeonia 15x, Plantago 15x, Quercus glandium spiritus 15x, Ratanhia 15x, Vipera berus 15x, Aesculus hipp. 3x, Echinacea 3x, Solidago 3x, Urtica ur. 3x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with hemorrhoids such as difficult elimination, itching, inflammation, burning pain and pressure.

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

PACKAGE LABEL.

Hemorrhoids

Elaps corallinus, Aesculus hipp., Aloe, Arsenicum alb., Bryonia, Calc. fluor., Capsicum, Collinsonia, Crotalus horridus, Hamamelis, Hydrofluoricum acidum, Hypericum, Lachesis, Lycopodium, Millefolium, Naja, Nux vom., Paeonia, Plantago, Quercus glandium spiritus, Ratanhia, Vipera berus, Echinacea, Solidago, Urtica ur. LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55714-2220
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]
HORSE CHESTNUT HORSE CHESTNUT 15 [hp_X]
ALOE ALOE 15 [hp_X]
ARSENIC TRIOXIDE ARSENIC TRIOXIDE 15 [hp_X]
BRYONIA ALBA ROOT BRYONIA ALBA ROOT 15 [hp_X]
CALCIUM FLUORIDE Fluoride Ion 15 [hp_X]
Capsicum CAPSICUM 15 [hp_X]
COLLINSONIA CANADENSIS ROOT COLLINSONIA CANADENSIS ROOT 15 [hp_X]
CROTALUS HORRIDUS HORRIDUS VENOM Crotalus Horridus Horridus Venom 15 [hp_X]
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 15 [hp_X]
Hydrofluoric Acid Hydrofluoric Acid 15 [hp_X]
Hypericum Perforatum HYPERICUM PERFORATUM 15 [hp_X]
LACHESIS MUTA VENOM LACHESIS MUTA VENOM 15 [hp_X]
Lycopodium Clavatum Spore LYCOPODIUM CLAVATUM SPORE 15 [hp_X]
ACHILLEA MILLEFOLIUM 15 [hp_X]
NAJA NAJA VENOM Naja Naja Venom 15 [hp_X]
STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED 15 [hp_X]
PAEONIA OFFICINALIS ROOT PAEONIA OFFICINALIS ROOT 15 [hp_X]
PLANTAGO MAJOR PLANTAGO MAJOR 15 [hp_X]
QUERCUS ROBUR NUT Quercus Robur Nut 15 [hp_X]
KRAMERIA LAPPACEA ROOT KRAMERIA LAPPACEA ROOT 15 [hp_X]
Vipera Berus Venom Vipera Berus Venom 15 [hp_X]
ECHINACEA, UNSPECIFIED Echinacea, Unspecified 3 [hp_X]
SOLIDAGO VIRGAUREA FLOWERING TOP SOLIDAGO VIRGAUREA FLOWERING TOP 3 [hp_X]
Urtica Urens URTICA URENS 3 [hp_X]

Inactive Ingredients

Ingredient Name Strength
ALCOHOL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55714-2220-1 29.57 in 1 BOTTLE, GLASS
2 NDC:55714-2220-2 59.14 in 1 BOTTLE, GLASS
3 NDC:55714-2220-0 .5 in 1 BOTTLE, GLASS

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-03-01


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