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  5. Label Information: Calming Composition

FDA Label for Calming Composition

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS:
    2. INDICATIONS:
    3. WARNINGS:
    4. KEEP OUT OF REACH OF CHILDREN:
    5. DIRECTIONS:
    6. INACTIVE INGREDIENTS:
    7. QUESTIONS:
    8. PACKAGE LABEL DISPLAY:

Calming Composition Product Label

The following document was submitted to the FDA by the labeler of this product Synergy Formulas, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients:



HUMULUS LUPULUS 1X, 3X,  VALERIANA OFFICINALIS 1X, 3X,  AVENA SATIVA 1X, 6X, 30X,  SCUTELLARIA LATERIFLORA 2X, 3X,  SUMBUL 3X,  MELILOTUS OFFICINALIS 3X, 6X,  PASSIFLORA INCARNATA 3X, 6X,  PHOSPHORUS 6X, 8X, 12X,  IGNATIA AMARA 6X, 12X,  MOSCHUS 8X, 10X,  ZINCUM METALLICUM 8X, 12X,  GLANDULA SUPRARENALIS SUIS 8X, 30X,  HYPOTHALAMUS (SUIS) 8X, 30X,  PULSATILLA (VULGARIS) 30X,  ACONITUM NAPELLUS 30X, 100X,  FERULA GLAUCA 6C


Indications:



Provides temporary relief of tickling cough, troublesome at night.  Pains in the joints, and bones. Cramps in calves and soles of feet.

Provides temporary relief of tickling cough, troublesome at night. Pains in the joints, and bones. Cramps in calves and soles of feet.


Warnings:



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

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

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


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.


Directions:



10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.


Inactive Ingredients:



Demineralized Water, 25% Ethanol


Questions:



Distributed by:

SYNERGY FORMULAS, INC.

251 West Road

Campobello, SC 29322


Package Label Display:



Synergy Formulas

CALMING COMPOSITION

HOMEOPATHIC

2 FL OZ (60 ml)


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