| NDC | 63388-910-44, 63388-910-45, 63388-910-49 |
| Set ID | fdc34e7c-1611-4aa0-a93a-7123644767a0 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Laboratoire Atlas Inc |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number |
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ACTIVE INGREDIENT
Active Ingredients HPUS:
Asafo etida (Asafetida) 8 [HP_ X] in 100 mL.
Ignatia amara (Ig natius bean) 8 [ HP_X] in 100 mL.
Valeriana officinalis (Valerian) 8 [HP_ X] in a 100 mL.
Avena sativa (Oats) 8 [HP_X] in a 100 mL.
Argentum nitricum (Silver nitrate) 8 [HP_X] in a 100 mL.
Hyoscyamus niger (Henbane) 8 [HP_ X] in a 100 mL.
Paeonia officinalis (Peony) 8 [ HP_ X] in a 100 ml
Stramonium (Thorn apple) 8 [HP_ X] in a 100 mL.
Cocculus indicus (Indian berry) 8
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PURPOSE
Purpose of the Drug:
[e.g. sunscreen, analgesic, etc.] Purpose
Restlessness and anxiety
Nervousness. Agitation
Sleeplessness Anguish and fear
Apprehension, anxiety and irritability
Nightmares and nervousness
Lack of concentration
The letters 'HPUS' indicate that the components in this product are officially monographed in the
Homeopathic Pharmacopoeia of the United States.
*These claims have not been reviewed or evalauted by the Food and Drug Administration. They are based on traditional homeopathic practice not
medical evidence.
Uses
This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms of:
Restlessness, nervousness, irritability, agitation, sleeplessness, lessens nightmares
- 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:63388-910 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:63388-910-49 1 in 1 CARTON 03/03/2018 1 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:63388-910-45 1 in 1 CARTON 03/03/2018 2 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:63388-910-44 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 - Laboratoire Atlas Inc (247880834)
