Drug Facts:

Drug Facts:
SPL v4
SPL
SPL Set ID ff9b8811-1883-42bc-bcf4-7b390237a619
Route
ORAL
Published
Effective Date 2024-09-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avena Sativa Flowering Top (2 [hp_X]) Hops (6 [hp_X]) Passiflora Incarnata Flowering Top (12 [hp_X]) Valerian Strychnos Ignatii Seed Scutellaria Lateriflora Whole Zinc
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2023-02-21

Description

(in each spray) Avena Sativa 2X, Humulus Lupulus 2X, Ignatia Amara 6X, Passiflora Incarnata 2X, Scutellaria Lateriflora 6X, Valeriana Officinalis 2X, Zincum Metallicum 12X.

Purpose

Avena Sativa – Relieves Effects of Anxiety, Sleep Enhancer,† Humulus Lupulus – Relieves Effects of Anxiety and Stress Related Conditions,† Ignatia Amara – Relieves Effects of Anxiety and Stress Related Conditions, Sleep Enhancer,† Passiflora Incarnata – Sleep Enhancer,† Scutellaria Lateriflora – Relieves Stress Related Conditions, Sleep Enhancer,† Valeriana Officinalis – Relieves Effects of Anxiety and Stress Related Conditions, Sleep Enhancer,† Zincum Metallicum – Relieves Stress Related Conditions, Sleep Enhancer†


Medication Information

Purpose

Avena Sativa – Relieves Effects of Anxiety, Sleep Enhancer,† Humulus Lupulus – Relieves Effects of Anxiety and Stress Related Conditions,† Ignatia Amara – Relieves Effects of Anxiety and Stress Related Conditions, Sleep Enhancer,† Passiflora Incarnata – Sleep Enhancer,† Scutellaria Lateriflora – Relieves Stress Related Conditions, Sleep Enhancer,† Valeriana Officinalis – Relieves Effects of Anxiety and Stress Related Conditions, Sleep Enhancer,† Zincum Metallicum – Relieves Stress Related Conditions, Sleep Enhancer†

Description

(in each spray) Avena Sativa 2X, Humulus Lupulus 2X, Ignatia Amara 6X, Passiflora Incarnata 2X, Scutellaria Lateriflora 6X, Valeriana Officinalis 2X, Zincum Metallicum 12X.

Uses:

For temporary relief of the effects of  anxiety and stress-related conditions, sleep enhancer.†

Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Purpose:

Avena Sativa – Relieves Effects of Anxiety, Sleep Enhancer,† Humulus Lupulus – Relieves Effects of Anxiety and Stress Related Conditions,† Ignatia Amara – Relieves Effects of Anxiety and Stress Related Conditions, Sleep Enhancer,† Passiflora Incarnata – Sleep Enhancer,† Scutellaria Lateriflora – Relieves Stress Related Conditions, Sleep Enhancer,† Valeriana Officinalis – Relieves Effects of Anxiety and Stress Related Conditions, Sleep Enhancer,† Zincum Metallicum – Relieves Stress Related Conditions, Sleep Enhancer†

Warnings:

If pregnant or breast-feeding, ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away.

If condition worsens, seek medical attention.

KEEP OUT OF REACH OF CHILDREN

Do not use if tamper evident seal is broken or missing.

Store in a cool place after opening

Questions:

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com

1-800-245-1313

Directions:

• Adults: 2 to 3 sprays orally, three times daily. Children under twelve one half adult dosage.

• Do not take within 15 minutes of consuming food, beverage or brushing teeth.

Consult a physician for use in children under 12 years of age.

Active Ingredients:

(in each spray) Avena Sativa 2X, Humulus Lupulus 2X, Ignatia Amara 6X, Passiflora Incarnata 2X, Scutellaria Lateriflora 6X, Valeriana Officinalis 2X, Zincum Metallicum 12X.

Inactive Ingredients:

Alcohol USP 20%, Purified Water USP.

Package Label Display:

Professional

Health Products

HOMEOPATHIC

NDC 83027-0013-1

NEURO CALMING

FORMULA

2 FL. OZ (60 ml)

Keep Out of Reach of Children:

In case of overdose, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses: (USES:)

For temporary relief of the effects of  anxiety and stress-related conditions, sleep enhancer.†

Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Purpose: (PURPOSE:)

Avena Sativa – Relieves Effects of Anxiety, Sleep Enhancer,† Humulus Lupulus – Relieves Effects of Anxiety and Stress Related Conditions,† Ignatia Amara – Relieves Effects of Anxiety and Stress Related Conditions, Sleep Enhancer,† Passiflora Incarnata – Sleep Enhancer,† Scutellaria Lateriflora – Relieves Stress Related Conditions, Sleep Enhancer,† Valeriana Officinalis – Relieves Effects of Anxiety and Stress Related Conditions, Sleep Enhancer,† Zincum Metallicum – Relieves Stress Related Conditions, Sleep Enhancer†

Warnings: (WARNINGS:)

If pregnant or breast-feeding, ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away.

If condition worsens, seek medical attention.

KEEP OUT OF REACH OF CHILDREN

Do not use if tamper evident seal is broken or missing.

Store in a cool place after opening

Questions: (QUESTIONS:)

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com

1-800-245-1313

Directions: (DIRECTIONS:)

• Adults: 2 to 3 sprays orally, three times daily. Children under twelve one half adult dosage.

• Do not take within 15 minutes of consuming food, beverage or brushing teeth.

Consult a physician for use in children under 12 years of age.

Active Ingredients: (ACTIVE INGREDIENTS:)

(in each spray) Avena Sativa 2X, Humulus Lupulus 2X, Ignatia Amara 6X, Passiflora Incarnata 2X, Scutellaria Lateriflora 6X, Valeriana Officinalis 2X, Zincum Metallicum 12X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Alcohol USP 20%, Purified Water USP.

Package Label Display: (PACKAGE LABEL DISPLAY:)

Professional

Health Products

HOMEOPATHIC

NDC 83027-0013-1

NEURO CALMING

FORMULA

2 FL. OZ (60 ml)

Keep Out of Reach of Children: (KEEP OUT OF REACH OF CHILDREN:)

In case of overdose, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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