FDA.reportPublic FDA data

Quiet Calm

Manufacturer
Holistic Haven | Apotheca Company
Effective date
2024-11-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:50:13

Label at a glance#

ProductQuiet Calm
Active ingredientAVENA SATIVA FLOWERING TOP, AMMONIUM BROMIDE, MATRICARIA CHAMOMILLA WHOLE, ARABICA COFFEE BEAN, GELSEMIUM SEMPERVIRENS ROOT, TRYPTOPHAN, PHOSPHORIC ACID, VALERIAN
Label structure9 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

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

INDICATIONS:

OTC - PURPOSE SECTION

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

WARNINGS:

WARNINGS SECTION

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:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

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:

INDICATIONS & USAGE SECTION

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

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Ethanol

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. By: Holistic Haven

Westlake Village, CA 91362

holistichavenpharmacy.com

1-866-676-HEAL

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Holistic Haven

Quiet

Calm

HOMEOPATHIC

2 FL OZ (59 ml)

Quiet CalmQuiet Calm

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70476-000470476-0004-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVENA SATIVA FLOWERING TOPMA9CQJ3F7FACTIB
AMMONIUM BROMIDER0JB3224WSACTIB
MATRICARIA CHAMOMILLA WHOLEG0R4UBI2ZZACTIB
ARABICA COFFEE BEAN3SW678MX72ACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
TRYPTOPHAN8DUH1N11BXACTIB
PHOSPHORIC ACIDE4GA8884NNACTIB
VALERIANJWF5YAW3QWACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1bbe9091-73c2-4263-af49-63f134c94d0ba151bcc7-c2b5-44e4-a61e-8e248c31733a2024-11-06WarningsExact identifier
spl id: 1bbe9091-73c2-4263-af49-63f134c94d0b
spl set id: a151bcc7-c2b5-44e4-a61e-8e248c31733a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.