Label: WITH CALMING EFFECT KIDS RELIEF- asafoetida, ignatia amara, valeriana officinalis, avena sativa, argentum nitricum, hyoscyamus niger, paeonia officinalis, stramonium, cocculus indicus syrup
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Contains inactivated NDC Code(s)
NDC Code(s): 60512-9164-5 - Packager: HOMEOLAB USA 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 April 2, 2014
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INGREDIENTS AND APPEARANCE
WITH CALMING EFFECT KIDS RELIEF
asafoetida, ignatia amara, valeriana officinalis, avena sativa, argentum nitricum, hyoscyamus niger, paeonia officinalis, stramonium, cocculus indicus syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60512-9164 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 VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN 8 [hp_X] in 100 mL AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP 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 SEED (UNII: 810258W28U) (ANAMIRTA COCCULUS SEED - UNII:810258W28U) ANAMIRTA COCCULUS SEED 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) Product Characteristics Color Score Shape Size Flavor GRAPE, RASPBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60512-9164-5 100 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/07/2013 Labeler - HOMEOLAB USA INC (202032533) Establishment Name Address ID/FEI Business Operations HOMEOLAB USA INC 202032533 manufacture(60512-9164)