Package Label

SPL v1
SPL
SPL Set ID cccc2bbe-3860-f121-9f44-78210b59e6f0
Route
ORAL
Published
Effective Date 2012-08-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

package label


Medication Information

Warnings and Precautions

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.  

Indications and Usage

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

Dosage and Administration

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.

Description

package label

Section 48780-1

package label

Section 50565-1

Keep out of reach of children. 

Section 51727-6

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

Section 53413-1

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

Section 53414-9

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

Section 55105-1

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

Section 55106-9

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.


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

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.  

Section 48780-1 (48780-1)

package label

Section 50565-1 (50565-1)

Keep out of reach of children. 

Section 51727-6 (51727-6)

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

Section 53413-1 (53413-1)

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

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

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

Section 55106-9 (55106-9)

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.


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