REAL 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

Real Relief Natural Wellness Calming Syrup by

Drug Labeling and Warnings

Real Relief Natural Wellness Calming Syrup by is a Homeopathic medication manufactured, distributed, or labeled by Homeolab International (Canada) inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

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

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

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

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.

KEEP OUT OF REACH OF CHILDREN

Directions

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

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

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

Product label

INGREDIENTS AND APPEARANCE

REAL 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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71971-9042
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FERULA ASSA-FOETIDA RESIN (UNII: W9FZA51AS1) (ASAFETIDA - UNII:W9FZA51AS1)	FERULA ASSA-FOETIDA RESIN	8 [hp_X]  in 100 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	8 [hp_X]  in 100 mL
VALERIANA OFFICINALIS WHOLE (UNII: FP6O7F1X9R) (VALERIANA OFFICINALIS WHOLE - UNII:FP6O7F1X9R)	VALERIANA OFFICINALIS WHOLE	8 [hp_X]  in 100 mL
OAT BRAN (UNII: KQX236OK4U) (OAT BRAN - UNII:KQX236OK4U)	OAT BRAN	8 [hp_X]  in 100 mL
SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A)	SILVER NITRATE	8 [hp_X]  in 100 mL
HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3)	HYOSCYAMUS NIGER	8 [hp_X]  in 100 mL
PAEONIA OFFICINALIS ROOT (UNII: 8R564U2E1P) (PAEONIA OFFICINALIS ROOT - UNII:8R564U2E1P)	PAEONIA OFFICINALIS ROOT	8 [hp_X]  in 100 mL
DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3)	DATURA STRAMONIUM	8 [hp_X]  in 100 mL
ANAMIRTA COCCULUS WHOLE (UNII: 8O4P2U3QO2) (ANAMIRTA COCCULUS WHOLE - UNII:8O4P2U3QO2)	ANAMIRTA COCCULUS WHOLE	8 [hp_X]  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
CARAMEL (UNII: T9D99G2B1R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71971-9042-5	1 in 1 CARTON	09/01/2022
1		100 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/01/2022

Labeler - Homeolab International (Canada) inc (203639455)