Drug Facts:

Drug Facts:
SPL v1
SPL
SPL Set ID cb740345-43fd-4f27-a182-62293a5c2e48
Route
ORAL
Published
Effective Date 2014-11-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hops (1 [hp_X]) Valerian (2 [hp_X]) Avena Sativa Flowering Top (3 [hp_X]) Scutellaria Lateriflora (6 [hp_X]) Ferula Sumbul Root (8 [hp_X]) Melilotus Officinalis Top (30 [hp_X]) Passiflora Incarnata Flowering Top (6 [hp_C]) Phosphorus Strychnos Ignatii Seed Moschus Moschiferus Musk Sac Resin Zinc Sus Scrofa Adrenal Gland Sus Scrofa Hypothalamus Pulsatilla Vulgaris Aconitum Napellus Ferula Communis Subsp. Glauca
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2014-11-17

Description

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


Medication Information

Description

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

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.

Questions:

Distributed by:

SYNERGY FORMULAS, INC.

251 West Road

Campobello, SC 29322

Directions:

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

Indications:

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

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

Inactive Ingredients:

Demineralized Water, 25% Ethanol

Package Label Display:

Synergy Formulas

CALMING COMPOSITION

HOMEOPATHIC

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.


Structured Label Content

Warnings: (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.

Questions: (QUESTIONS:)

Distributed by:

SYNERGY FORMULAS, INC.

251 West Road

Campobello, SC 29322

Directions: (DIRECTIONS:)

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

Indications: (INDICATIONS:)

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

Active Ingredients: (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

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Ethanol

Package Label Display: (PACKAGE LABEL DISPLAY:)

Synergy Formulas

CALMING COMPOSITION

HOMEOPATHIC

2 FL OZ (60 ml)

Keep Out of Reach of Children: (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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