Label: 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
- NDC Code(s): 71971-9042-5
- Packager: Homeolab International (Canada) inc
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated November 3, 2022
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- Official Label (Printer Friendly)
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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.
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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
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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
- KEEP OUT OF REACH OF CHILDREN
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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
- Inactive ingredients
- Product label
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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) liquidProduct 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)