NDC | 62106-1138-8 |
Set ID | 0cc8aa90-b341-1f90-e054-00144ff88e88 |
Category | HUMAN OTC DRUG LABEL |
Packager | Seroyal USA |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
-
INDICATIONS & USAGE
Uses
For the temporary relief of minor symptoms
associated with irritability and anxiousness.Directions
Adults and adolescents (12 years and older)
Take 5 drops three times daily or as recommended by your healthcare practitioner.
Children (under 12 years)
Take under the direction of your healthcare practitioner.
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
UNDA 39
asafoetida gum resin,absinthium, allium cepa, tanacetum vulgare aerial parts, cina flower-heads, dryopteris filix-mas rhizome, argentum metallicum liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62106-1138 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DRYOPTERIS FILIX-MAS ROOT (UNII: C0ZK0RRF5X) (DRYOPTERIS FILIX-MAS ROOT - UNII:C0ZK0RRF5X) DRYOPTERIS FILIX-MAS ROOT 6 [hp_X] in 20 mL ARTEMISIA CINA PRE-FLOWERING TOP (UNII: 28M1820ACT) (ARTEMISIA CINA PRE-FLOWERING TOP - UNII:28M1820ACT) ARTEMISIA CINA PRE-FLOWERING TOP 6 [hp_X] in 20 mL SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G) SILVER 12 [hp_X] in 20 mL ASAFETIDA (UNII: W9FZA51AS1) (ASAFETIDA - UNII:W9FZA51AS1) ASAFETIDA 4 [hp_X] in 20 mL WORMWOOD (UNII: F84709P2XV) (WORMWOOD - UNII:F84709P2XV) WORMWOOD 4 [hp_X] in 20 mL ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION 4 [hp_X] in 20 mL TANACETUM VULGARE TOP (UNII: D52957JQ8M) (TANACETUM VULGARE TOP - UNII:D52957JQ8M) TANACETUM VULGARE TOP 4 [hp_X] in 20 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62106-1138-8 1 in 1 CARTON 01/16/2015 1 20 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/16/2015 Labeler - Seroyal USA (018361118) Establishment Name Address ID/FEI Business Operations SAN’UP 401010287 manufacture(62106-1138)