Aches - Pains description, usages, side effects, indications, overdosage, supplying and lots more!

Aches - Pains

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
Aches - Pains

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

INDICATIONS & USAGE SECTION

Aches - Pains   Formulated for symptoms associated with bruises, strains and overexertion such as pain, stiffness and inflammation.

Directions:  Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) as needed or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purfied water.  Sensitive persons begin with 1 pellet and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Aconitum nap. 15x, Arg. nit. 15x, Arnica 15x, Bryonia 15x, Colchicum 15x, Guaiacum 15x, Hypericum 15x, Kalmia latifolia 15x, Phosphorus 15x, Phytolacca 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Ruta 15x, Sarcolacticum ac. 15x, Sticta 15x, Stramonium 15x, Hamamelis 3x, Phytolacca 3x, Ruta 3x, Taraxacum 3x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with bruises, strains and overexertion such as pain, stiffness and inflammation.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.

OTC - 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

Aches - Pains

Aconitum nap., Arg. nit., Arnica, Bryonia, Colchicum, Guaiacum, Hypericum, Kalmia, Phosphorus, Phytolacca, Pulsatilla, Rhus toxicodendron, Ruta, Sarcolacticum ac., Sticta, Stramonium, Hamamelis, Taraxacum, PELLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55714-2237
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACONITUM NAPELLUS ACONITUM NAPELLUS 15 [hp_X]
SILVER NITRATE SILVER CATION 15 [hp_X]
ARNICA MONTANA ARNICA MONTANA 15 [hp_X]
BRYONIA ALBA ROOT BRYONIA ALBA ROOT 15 [hp_X]
COLCHICUM AUTUMNALE BULB COLCHICUM AUTUMNALE BULB 15 [hp_X]
GUAIAC Guaiac 15 [hp_X]
Hypericum Perforatum HYPERICUM PERFORATUM 15 [hp_X]
kalmia latifolia leaf KALMIA LATIFOLIA LEAF 15 [hp_X]
PHOSPHORUS PHOSPHORUS 15 [hp_X]
PHYTOLACCA AMERICANA ROOT PHYTOLACCA AMERICANA ROOT 15 [hp_X]
PULSATILLA VULGARIS PULSATILLA VULGARIS 15 [hp_X]
TOXICODENDRON PUBESCENS LEAF TOXICODENDRON PUBESCENS LEAF 15 [hp_X]
RUTA GRAVEOLENS FLOWERING TOP RUTA GRAVEOLENS FLOWERING TOP 15 [hp_X]
LACTIC ACID, L- LACTIC ACID, L- 15 [hp_X]
LOBARIA PULMONARIA LOBARIA PULMONARIA 15 [hp_X]
DATURA STRAMONIUM DATURA STRAMONIUM 15 [hp_X]
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 3 [hp_X]
TARAXACUM OFFICINALE Taraxacum Officinale 3 [hp_X]

Inactive Ingredients

Ingredient Name Strength
SUCROSE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55714-2237-1 28.35 in 1 BOTTLE, GLASS
2 NDC:55714-2237-2 56.7 in 1 BOTTLE, GLASS
3 NDC:55714-2237-0 7.08 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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