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 
Homeolab International (Canada) inc

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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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.

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

image descriptionimage description

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:71971-9042
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERULA ASSA-FOETIDA RESIN (UNII: W9FZA51AS1) (ASAFETIDA - UNII:W9FZA51AS1) FERULA ASSA-FOETIDA RESIN8 [hp_X]  in 100 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED8 [hp_X]  in 100 mL
VALERIANA OFFICINALIS WHOLE (UNII: FP6O7F1X9R) (VALERIANA OFFICINALIS WHOLE - UNII:FP6O7F1X9R) VALERIANA OFFICINALIS WHOLE8 [hp_X]  in 100 mL
OAT BRAN (UNII: KQX236OK4U) (OAT BRAN - UNII:KQX236OK4U) OAT BRAN8 [hp_X]  in 100 mL
SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE8 [hp_X]  in 100 mL
HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER8 [hp_X]  in 100 mL
PAEONIA OFFICINALIS ROOT (UNII: 8R564U2E1P) (PAEONIA OFFICINALIS ROOT - UNII:8R564U2E1P) PAEONIA OFFICINALIS ROOT8 [hp_X]  in 100 mL
DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3) DATURA STRAMONIUM8 [hp_X]  in 100 mL
ANAMIRTA COCCULUS WHOLE (UNII: 8O4P2U3QO2) (ANAMIRTA COCCULUS WHOLE - UNII:8O4P2U3QO2) ANAMIRTA COCCULUS WHOLE8 [hp_X]  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
CARAMEL (UNII: T9D99G2B1R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71971-9042-51 in 1 CARTON09/01/2022
1100 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/01/2022
Labeler - Homeolab International (Canada) inc (203639455)

Revised: 11/2022
Document Id: ec97a8da-436c-e7e0-e053-2a95a90a7b7f
Set id: fb8c8d6d-3c7a-459d-97a8-d9094f3d546c
Version: 3
Effective Time: 20221103
 
Homeolab International (Canada) inc