Label: KIDS RELIEF- asafoetida, ignatia amara, valeriana officinalis, avena sativa, argentum nitricum, hyoscyamus niger, paeonia officinalis, stramonium, cocculus indicus liquid
- NDC Code(s): 71971-9104-4, 71971-9104-5, 71971-9104-9
- Packager: Homeolab International (Canada) inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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 December 10, 2019
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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PURPOSE
Purpose of the Drug:
Asafoetida 8X..............................restlessness and anxiety
Ignatia amara 8X.........................nervousness
Valeriana officinalis 8X..................agitation
Avena sativa 8X...........................sleeplessness
Argentum nitricum 8X...................nervousness
Hyoscyamus niger 8X...................anguish and fear
Paeonia officinalis 8X....................apprehension, anxiety and irritability
Stramonium 8X............................nightmares and nervousness
Cocculus indicus 8X......................lack of concentration
The letters 'HPUS' indicate that the components in this product are officially monographed in the
Homeopathic Pharmacopoeia of the United States.
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- KEEP OUT OF REACH OF CHILDREN
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
KIDS RELIEF
asafoetida, ignatia amara, valeriana officinalis, avena sativa, argentum nitricum, hyoscyamus niger, paeonia officinalis, stramonium, cocculus indicus liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71971-9104 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASAFETIDA (UNII: W9FZA51AS1) (ASAFETIDA - UNII:W9FZA51AS1) ASAFETIDA 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) 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:71971-9104-9 1 in 1 CARTON 03/03/2018 1 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:71971-9104-5 1 in 1 CARTON 03/03/2018 2 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:71971-9104-4 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/03/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/03/2018 Labeler - Homeolab International (Canada) inc (203639455)
