Real Relief Natural Wellness Calming Syrup

Manufacturer
Homeolab International (Canada) inc
Effective date
2022-11-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:18:21

Label at a glance#

ProductReal Relief Natural Wellness Calming Syrup
Active ingredientFERULA ASSA-FOETIDA RESIN, STRYCHNOS IGNATII SEED, VALERIANA OFFICINALIS WHOLE, OAT BRAN, SILVER NITRATE, HYOSCYAMUS NIGER, PAEONIA OFFICINALIS ROOT, DATURA STRAMONIUM, ANAMIRTA COCCULUS WHOLE
Label structure8 sections

Indications and uses

This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms of*: restlessness, nervousness, irritability, agitation, sleeplessness, lessen nightmares. *These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice, not medical evidence.

Dosage and administration

• Do not exceed recommended dosage • Repeat every 6 hours and reduce with improvement or as directed by a health professional. Age………………………………………………………….................Dose Adults and Children 12 + years. ............................................10 ml or 2 teaspoon (tsp) Children 6 to 11 years of age. ...............................................5 ml or 1 teaspoon (tsp) Children 2 to 5 years of age. ...........

Storage and handling

Store at room temperature.• Do not use if seal is broken or missing *These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice, not medical evidence.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

ASAFOETIDA (ASAFETIDA) 8 [hp-X]

IGNATIA AMARA (IGNATUS BEAN)                        8 [hp-X]

VALERIANA OFFICINALIS (VALERIAN)                8 [hp-X]

AVENA SATIVA (OAT)                                                 8 [hp-X]

ARGENTUM NITRICUM (SILVER NITRATE)          8 [hp-X]

HYOSCYAMUS NIGER (HENBANE)                        8 [hp-X]

PAEONIA OFFICINALIS (PEONY)                             8 [hp-X]

STRAMONIUM (THORN APPLE)                               8 [hp-X]

ANCOCCULUS INDICUS (INDIAN BERRY)             8 [hp-X]

The letters 'HPUS' indicate that the compo nents in this pro duct are o fficially mo no g raphed in the Ho mo eo pathic Pharmaco po eia o f the United States.

Purpose

OTC - PURPOSE SECTION

ASAFOETIDA                                  Restlessness and Anxiety

IGNATIA AMARA                            Nervousness

VALERIANA OFFICINALIS                Agitation

AVENA SATIVA                              Sleeplessness

ARGENTUM NITRICUM                   Nervousness

ARGENTUM NITRICUM                   Nervousness

HYOSCYAMUS NIGER                    Anguish and fear

PAEONIA OFFICINALIS                 Apprehension, anxiety and irritability

STRAMONIUM                             Nightmares and nervousness

COCCULUS INDICUS                    Lack of concentration

Uses

INDICATIONS & USAGE SECTION

This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms of*: restlessness, nervousness, irritability, agitation, sleeplessness, lessen nightmares.

*These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice, not medical evidence.

Warnings

WARNINGS SECTION

Stop use and ask a doctor if symptoms worsen:

If you are pregnant or breast feeding, ask a health professional before.

Keep out of reach of children. In case of accidental overdose, contact a medical
professional or poison control center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

• Do not exceed recommended dosage

• Repeat every 6 hours and reduce with improvement or as directed by a health professional.
Age………………………………………………………….................Dose
Adults and Children 12 + years. ............................................10 ml or 2 teaspoon (tsp)
Children 6 to 11 years of age. ...............................................5 ml or 1 teaspoon (tsp)
Children 2 to 5 years of age. .................................................2.5 ml or ½ teaspoon (tsp)

Other information

STORAGE AND HANDLING SECTION

Store at room temperature.• Do not use if seal is broken or missing

*These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice, not medical evidence.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified water, sorbitol, grape and raspberry flavor, sodium benzoate, potassium sorbate, citric acid.

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71971-9042-5Real Relief Natural Wellness Calming Syrup1 in 1 CARTONLIQUID13
71971-9042-5Real Relief Natural Wellness Calming Syrup100 mL in 1 BOTTLELIQUID1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71971-9042REAL RELIEF NATURAL WELLNESS CALMING SYRUP (ASAFOETIDA, STRYCHNOS IGNATII SEED (IGNATIA AMARA), VALERIANA OFFICINALIS WHOLE (VALERIANA OFFICINALIS), OAT BRAN (AVENA SATIVA), SILVER NITRATE (ARGENTUM NITRICUM), HYOSCYAMUS NIGER, PAEONIA OFFICINALIS ROOT (PAEONIA OFFICINALIS), DATURA STRAMONIUM, ANAMIRTA COCCULUS WHOLE (COCCULUS INDICUS)) LIQUID [HOMEOLAB INTERNATIONAL (CANADA) INC]3Current NDC, Legacy NDC, 2 package rows20221104_fb8c8d6d-3c7a-459d-97a8-d9094f3d546c.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71971-904271971-9042-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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
Real Relief Natural Wellness Calming SyrupASAFOETIDA, STRYCHNOS IGNATII SEED (IGNATIA AMARA), VALERIANA OFFICINALIS WHOLE (VALERIANA OFFICINALIS), OAT BRAN (AVENA SATIVA), SILVER NITRATE (ARGENTUM NITRICUM), HYOSCYAMUS NIGER, PAEONIA OFFICINALIS ROOT (PAEONIA OFFICINALIS), DATURA STRAMONIUM, ANAMIRTA COCCULUS WHOLE (COCCULUS INDICUS)Homeolab International (Canada) incfb8c8d6d-3c7a-459d-97a8-d9094f3d546c2022-11-03WarningsExact identifier
ndc (package): 71971-9042-5
ndc (product): 71971-9042
ndc11 (package): 71971904205
spl id: ec97a8da-436c-e7e0-e053-2a95a90a7b7f
spl set id: fb8c8d6d-3c7a-459d-97a8-d9094f3d546c

Reported adverse events (FAERS/openFDA)#

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