CALMING COMPOSITION- not applicable liquid

CALMING COMPOSITION by

Drug Labeling and Warnings

CALMING COMPOSITION by is a Homeopathic medication manufactured, distributed, or labeled by Synergy Formulas, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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.

INDICATIONS:

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

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)

INGREDIENTS AND APPEARANCE

CALMING COMPOSITION 
not applicable liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43772-0044
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83)	HOPS	1 [hp_X]  in 1 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	1 [hp_X]  in 1 mL
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	1 [hp_X]  in 1 mL
SCUTELLARIA LATERIFLORA (UNII: 7BP4DH5PDC) (SCUTELLARIA LATERIFLORA - UNII:7BP4DH5PDC)	SCUTELLARIA LATERIFLORA	2 [hp_X]  in 1 mL
FERULA SUMBUL ROOT (UNII: GLA4808EHQ) (FERULA SUMBUL ROOT - UNII:GLA4808EHQ)	FERULA SUMBUL ROOT	3 [hp_X]  in 1 mL
MELILOTUS OFFICINALIS TOP (UNII: GM6P02J2DX) (MELILOTUS OFFICINALIS TOP - UNII:GM6P02J2DX)	MELILOTUS OFFICINALIS TOP	3 [hp_X]  in 1 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	3 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	6 [hp_X]  in 1 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	6 [hp_X]  in 1 mL
MOSCHUS MOSCHIFERUS MUSK SAC RESIN (UNII: 8KFK4W7KP7) (MOSCHUS MOSCHIFERUS MUSK SAC RESIN - UNII:8KFK4W7KP7)	MOSCHUS MOSCHIFERUS MUSK SAC RESIN	8 [hp_X]  in 1 mL
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS)	ZINC	8 [hp_X]  in 1 mL
SUS SCROFA ADRENAL GLAND (UNII: 398IYQ16YV) (SUS SCROFA ADRENAL GLAND - UNII:398IYQ16YV)	SUS SCROFA ADRENAL GLAND	8 [hp_X]  in 1 mL
SUS SCROFA HYPOTHALAMUS (UNII: N6R0856Z79) (SUS SCROFA HYPOTHALAMUS - UNII:N6R0856Z79)	SUS SCROFA HYPOTHALAMUS	8 [hp_X]  in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	30 [hp_X]  in 1 mL
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	30 [hp_X]  in 1 mL
FERULA COMMUNIS SUBSP. GLAUCA (UNII: 5S9H7NQT11) (FERULA COMMUNIS SUBSP. GLAUCA - UNII:5S9H7NQT11)	FERULA COMMUNIS SUBSP. GLAUCA	6 [hp_C]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43772-0044-1	60 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		11/17/2014

Labeler - Synergy Formulas, Inc. (069579220)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43772-0044) , api manufacture(43772-0044) , label(43772-0044) , pack(43772-0044)