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

Bedwetting

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
Bedwetting

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

INDICATIONS & USAGE SECTION

Bedwetting    Formulated for associated symptoms often related to fear, nervousness, muscle tone, trauma and bladder weakness.

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL.  Children, ages 0 to 11, give 3 drops orally (ages 12 and up, give 6 drops) one hour before bedtime, and then again at bedtime. Repeat as needed or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Belladonna 15x, Cantharis 15x ,Causticum 15x, Equisetum hyemale 15x, Ferrum metallicum 15x, Gelsemium 15x, Humulus 15x, Kali phos. 15x, Lycopodium 15x, Nat.mur. 15x, Plantago 15x, Pulsatilla 15x, Rhus aromatica 15x,Sabal 15x, Thyroidinum 15x, Verbascum 15x, Echinacea 3x, Hydrastis 3x, Passiflora 3x, Valeriana 3x.

OTC - PURPOSE SECTION

Formulated for associated symptoms often related to fear, nervousness, muscle tone, trauma and bladder weakness.

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

Bedwetting

Belladonna, Cantharis, Causticum, Equisetum hyemale, Ferrum metallicum, Gelsemium, Humulus, Kali phos., Lycopodium, Nat.mur., Plantago, Pulsatilla, Rhus aromatica, Sabal, Thyroidinum, Verbascum, Echinacea, Hydrastis, Passiflora, Valeriana LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55714-1513
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ATROPA BELLADONNA ATROPA BELLADONNA 15 [hp_X]
LYTTA VESICATORIA LYTTA VESICATORIA 15 [hp_X]
CAUSTICUM CAUSTICUM 15 [hp_X]
EQUISETUM HYEMALE EQUISETUM HYEMALE 15 [hp_X]
IRON IRON 15 [hp_X]
GELSEMIUM SEMPERVIRENS ROOT GELSEMIUM SEMPERVIRENS ROOT 15 [hp_X]
HOPS HOPS 15 [hp_X]
potassium phosphate, dibasic PHOSPHATE ION 15 [hp_X]
Lycopodium Clavatum Spore LYCOPODIUM CLAVATUM SPORE 15 [hp_X]
SODIUM CHLORIDE 15 [hp_X]
PLANTAGO MAJOR PLANTAGO MAJOR 15 [hp_X]
PULSATILLA VULGARIS PULSATILLA VULGARIS 15 [hp_X]
RHUS AROMATICA ROOT BARK Rhus Aromatica Root Bark 15 [hp_X]
SAW PALMETTO SAW PALMETTO 15 [hp_X]
THYROID, UNSPECIFIED THYROID, UNSPECIFIED 15 [hp_X]
VERBASCUM THAPSUS VERBASCUM THAPSUS 15 [hp_X]
ECHINACEA, UNSPECIFIED Echinacea, Unspecified 3 [hp_X]
GOLDENSEAL GOLDENSEAL 3 [hp_X]
Passiflora Incarnata Flowering Top PASSIFLORA INCARNATA FLOWERING TOP 3 [hp_X]
Valerian VALERIAN 3 [hp_X]

Inactive Ingredients

Ingredient Name Strength
ALCOHOL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55714-1513-1 29.57 in 1 BOTTLE, GLASS
2 NDC:55714-1513-2 59.14 in 1 BOTTLE, GLASS
3 NDC:55714-1513-0 .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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