QUIET CALM- avena sativa, ammonium bromatum, chamomilla, coffea cruda, gelsemium sempervirens, l-tryptophan, phosphoricum acidum, valeriana officinalis liquid
Holistic Haven

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Drug Facts:

ACTIVE INGREDIENTS:

Avena Sativa 1X, Ammonium Bromatum 3X, Chamomilla 6X, Coffea Cruda 6X, Gelsemium Sempervirens 6X, L-Tryptophan 6X, Phosphoricum Acidum 6X, Valeriana Officinalis 30X.

INDICATIONS:

For the temporary relief of symptoms related to sleep dysfunction, mood swings, and nervous anxiety.

WARNINGS:

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

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

Do not use if seal is broken or missing.

Store in a cool dry place.

KEEP OUT OF REACH OF CHILDREN:

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

DIRECTIONS:

10 drops orally, 3 times a day or as directed by a health care professional. Consult a physician for use in children under 12 years of age.

INDICATIONS:

For the temporary relief of symptoms related to sleep dysfunction, mood swings, and nervous anxiety.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

QUESTIONS:

Dist. By: Holistic Haven

Westlake Village, CA 91362

holistichavenpharmacy.com

1-866-676-HEAL

PACKAGE LABEL DISPLAY:

Holistic Haven

Quiet

Calm

HOMEOPATHIC

2 FL OZ (59 ml)

Quiet Calm

QUIET CALM
avena sativa, ammonium bromatum, chamomilla, coffea cruda, gelsemium sempervirens, l-tryptophan, phosphoricum acidum, valeriana officinalis liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70476-0004
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	1 [hp_X] in 1 mL
AMMONIUM BROMIDE (UNII: R0JB3224WS) (BROMIDE ION - UNII:952902IX06)	AMMONIUM BROMIDE	3 [hp_X] in 1 mL
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	6 [hp_X] in 1 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	6 [hp_X] in 1 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	6 [hp_X] in 1 mL
TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX)	TRYPTOPHAN	6 [hp_X] in 1 mL
PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN)	PHOSPHORIC ACID	6 [hp_X] in 1 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	30 [hp_X] in 1 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70476-0004-1	59 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	10/10/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		10/10/2019

Labeler - Holistic Haven (005153286)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(70476-0004) , api manufacture(70476-0004) , label(70476-0004) , pack(70476-0004)

Revised: 10/2019

Document Id: 99e93e90-1596-4b28-9125-1ec30ff78f52

Set id: a151bcc7-c2b5-44e4-a61e-8e248c31733a

Version: 1

Effective Time: 20191010

Holistic Haven