Peacefuli

Manufacturer
Ratis, LLC
Effective date
2023-05-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:21:17

Label at a glance#

ProductPeacefuli
Active ingredientAVENA SATIVA FLOWERING TOP, HOPS, PASSIFLORA INCARNATA FLOWERING TOP, DIBASIC POTASSIUM PHOSPHATE, PHOSPHORIC ACID, SEMECARPUS ANACARDIUM JUICE, SILVER NITRATE, STRYCHNOS IGNATII SEED
Label structure9 sections

Indications and uses

May temporarily relieve anxiousness, stress, and physical exhaustion and help you sleep.* *Claims based on traditional homeopathic practice, not accepted medial evidence. Not FDA evaluated.

Dosage and administration

• Adults: 2 sprays 3 times a day or as needed. • Children under 12: 1 spray as above • Consult a physician for use in children under 6 years of age. Store in a cool, dry place.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT:

OTC - ACTIVE INGREDIENT SECTION

(in each drop) Avena Sativa 3X 12.50%, Humulus Lupulus 3X 12.50%, Passiflora Incarnata 3X 12.50%, Kali Phosphoricum 6X 12.50%, Phosphoricum Acidum 6X 12.50%, Anacardium Orientale 6C 12.50%, Argentum Nitricum 6C 12.50%, Ignatia Amara 6C 12.50%.

PURPOSE:

OTC - PURPOSE SECTION

Avena Sativa – nervousness, sleeplessness,* Humulus Lupulus – overexcitement, tension,* Passiflora Incarnata – worries, insomnia,* Kali Phosphoricum – overwork, fatigue,* Phosphoricum Acidum – mental exhaustion,* Anacardium Orientale – doubt, apprehension, * Argentum Nitricum – fear, anxiousness,* Ignatia Amara – hypersensitivity, grief.*

USES:

INDICATIONS & USAGE SECTION

May temporarily relieve anxiousness, stress, and physical exhaustion and help you sleep.*

*Claims based on traditional homeopathic practice, not accepted medial evidence. Not FDA evaluated.

WARNINGS:

WARNINGS SECTION

For oral use only.

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

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

DO NOT USE IF TAMPER EVIDENT SEAL IS BROKEN OR MISSING

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

• Adults: 2 sprays 3 times a day or as needed.

• Children under 12: 1 spray as above

• Consult a physician for use in children under 6 years of age.

Store in a cool, dry place.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Citric acid, demineralized water, organic ethanol 1.6%, glycerin

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by Ratis, LLC:

1201 N Orange St,

Ste 7594

Wilmington, DE 19801

www.HomeopathyStore.com

(888) 405-7551

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LACTOSE FREE

ANNA

KARE

Peacefuli

ANXIETY & STRESS RELIEF*

HOMEOPATHIC ORAL SPRAY

1 FL. OZ (30ML)

PeacefuliPeacefuli

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71753-4001-1Peacefuli30 mL in 1 BOTTLE, SPRAYSPRAY303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71753-4001PEACEFULI (AVENA SATIVA, HUMULUS LUPULUS, PASSIFLORA INCARNATA, KALI PHOSPHORICUM, ANACARDIUM ORIENTALE, ARGENTUM NITRICUM, IGNATIA AMARA) SPRAY [RATIS, LLC]3Current NDC, Legacy NDC, 1 package rows20230526_eb3bc662-3d3d-4e4d-8561-330ad0eb08f2.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71753-400171753-4001-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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
PeacefuliAVENA SATIVA, HUMULUS LUPULUS, PASSIFLORA INCARNATA, KALI PHOSPHORICUM, ANACARDIUM ORIENTALE, ARGENTUM NITRICUM, IGNATIA AMARARatis, LLCeb3bc662-3d3d-4e4d-8561-330ad0eb08f22023-05-25WarningsExact identifier
ndc (package): 71753-4001-1
ndc (product): 71753-4001
ndc11 (package): 71753400101
spl id: a8612e96-b081-4670-9de0-810bceee06bb
spl set id: eb3bc662-3d3d-4e4d-8561-330ad0eb08f2

Reported adverse events (FAERS/openFDA)#

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