Bedwetting

Bedwetting
SPL v1
SPL
SPL Set ID 4f9cb2c5-e9f1-bf51-8603-a712abffb670
Route
ORAL
Published
Effective Date 2012-08-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Atropa Belladonna (15 [hp_X]) Lytta Vesicatoria (3 [hp_X]) Causticum Equisetum Hyemale Iron Gelsemium Sempervirens Root Hops Phosphate Ion Lycopodium Clavatum Spore Chloride Ion Plantago Major Pulsatilla Vulgaris Rhus Aromatica Root Bark Saw Palmetto Thyroid, Unspecified Verbascum Thapsus Echinacea, Unspecified Goldenseal Passiflora Incarnata Flowering Top Valerian
Inactive Ingredients
Sucrose

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2011-03-01

Description

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

Purpose

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


Medication Information

Purpose

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

Description

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

Package Label

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.  

Questions Section

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

Questions?  1.800.448.7256 

Otc Purpose Section

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

Inactive Ingredient Section

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

Indications & Usage Section

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

Dosage & Administration Section

Directions:  Children, ages 0 to 11, give 3 pellets orally (ages 12 and up, give 6 pellets) one hour before bedtime, and then again at bedtime. Repeat as needed or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water.  Sensitive persons begin with 1 pellet 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 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. 


Structured Label Content

Package Label (PACKAGE LABEL)

Warnings Section (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.  

Questions Section (QUESTIONS SECTION)

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

Questions?  1.800.448.7256 

Otc Purpose Section (OTC - PURPOSE SECTION)

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

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

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

Indications & Usage Section (INDICATIONS & USAGE SECTION)

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

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions:  Children, ages 0 to 11, give 3 pellets orally (ages 12 and up, give 6 pellets) one hour before bedtime, and then again at bedtime. Repeat as needed or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water.  Sensitive persons begin with 1 pellet and gradually increase to full dose.

Otc Active Ingredient Section (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 Pregnancy Or Breast Feeding Section (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 (OTC - KEEP OUT OF REACH OF CHILDREN SECTION)

Keep out of reach of children. 


Advanced Ingredient Data


Raw Label Data

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