| NDC | 62106-1109-8, 62106-1162-8 |
| Set ID | 20ea57db-ad94-2c1c-e054-00144ff88e88 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Seroyal USA |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number |
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
- DOSAGE & ADMINISTRATION
-
INDICATIONS & USAGE
Uses
For the temporary relief of minor symptoms associated with occasional irregular menstrual cycles.
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. - ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
UNDA 10
absinthium, argentum metallicum, equisetum arvense, juniperus communis, millefolium, rhamnus frangula liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62106-1109 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WORMWOOD (UNII: F84709P2XV) (WORMWOOD - UNII:F84709P2XV) WORMWOOD 4 [hp_X] in 20 mL SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G) SILVER 12 [hp_X] in 20 mL EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E) (EQUISETUM ARVENSE BRANCH - UNII:1L0VKZ185E) EQUISETUM ARVENSE BRANCH 4 [hp_X] in 20 mL JUNIPER BERRY (UNII: O84B5194RL) (JUNIPER BERRY - UNII:O84B5194RL) JUNIPER BERRY 4 [hp_X] in 20 mL ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK) ACHILLEA MILLEFOLIUM 4 [hp_X] in 20 mL FRANGULA ALNUS BARK (UNII: S2D77IH61R) (FRANGULA ALNUS BARK - UNII:S2D77IH61R) FRANGULA ALNUS BARK 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:62106-1109-8 1 in 1 CARTON 09/29/2015 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 09/29/2015 UNDA 243
boldo leaf, cholesterinum, combretum micranthum, lycopodium clavatum, podophyllum peltatum liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62106-1162 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PEUMUS BOLDUS LEAF (UNII: Q4EWM09M3O) (PEUMUS BOLDUS LEAF - UNII:Q4EWM09M3O) PEUMUS BOLDUS LEAF 4 [hp_X] in 20 mL CHOLESTEROL (UNII: 97C5T2UQ7J) (CHOLESTEROL - UNII:97C5T2UQ7J) CHOLESTEROL 12 [hp_X] in 20 mL COMBRETUM MICRANTHUM LEAF (UNII: 8502S3Z5N1) (COMBRETUM MICRANTHUM LEAF - UNII:8502S3Z5N1) COMBRETUM MICRANTHUM LEAF 4 [hp_X] in 20 mL LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 4 [hp_X] in 20 mL PODOPHYLLUM PELTATUM ROOT (UNII: 2S713A4VP3) (PODOPHYLLUM PELTATUM ROOT - UNII:2S713A4VP3) PODOPHYLLUM PELTATUM ROOT 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:62106-1162-8 1 in 1 CARTON 09/29/2015 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 09/29/2015 Labeler - Seroyal USA (018361118) Establishment Name Address ID/FEI Business Operations SAN’UP 401010287 manufacture(62106-1109, 62106-1162)
