Label: UNDA 49- aurum metallicum, condurango bark, hypericum perforatum, ocimum basilicum, plumbum metallicum liquid
UNDA 74- boldo leaf, cynara scolymus, hamamelis virginiana, lycopodium clavatum, sepia inky juice liquid
- NDC Code(s): 62106-1148-8, 62106-1150-8
- Packager: Seroyal USA
- 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 November 9, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- 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 symptoms associated with low energy and fatigueDirections
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
Uses
For the temporary relief of symptoms associated with mild digestive distress.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. - PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
UNDA 49
aurum metallicum, condurango bark, hypericum perforatum, ocimum basilicum, plumbum metallicum liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62106-1148 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GOLD (UNII: 79Y1949PYO) (GOLD - UNII:79Y1949PYO) GOLD 12 [hp_X] in 20 mL MARSDENIA CONDURANGO BARK (UNII: R23QIR6YBA) (MARSDENIA CONDURANGO BARK - UNII:R23QIR6YBA) MARSDENIA CONDURANGO BARK 5 [hp_X] in 20 mL BASIL (UNII: 2U0KZP0FDW) (BASIL - UNII:2U0KZP0FDW) BASIL 5 [hp_X] in 20 mL LEAD (UNII: 2P299V784P) (LEAD - UNII:2P299V784P) LEAD 12 [hp_X] in 20 mL HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 5 [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:62106-1148-8 1 in 1 CARTON 09/22/2015 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 09/22/2015 UNDA 74
boldo leaf, cynara scolymus, hamamelis virginiana, lycopodium clavatum, sepia inky juice liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62106-1150 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 6 [hp_X] in 20 mL CYNARA SCOLYMUS LEAF (UNII: B71UA545DE) (CYNARA SCOLYMUS LEAF - UNII:B71UA545DE) CYNARA SCOLYMUS LEAF 4 [hp_X] in 20 mL HAMAMELIS VIRGINIANA BARK (UNII: IH3063S9MY) (HAMAMELIS VIRGINIANA BARK - UNII:IH3063S9MY) HAMAMELIS VIRGINIANA BARK 4 [hp_X] in 20 mL SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE 6 [hp_X] in 20 mL PEUMUS BOLDUS LEAF (UNII: Q4EWM09M3O) (PEUMUS BOLDUS LEAF - UNII:Q4EWM09M3O) PEUMUS BOLDUS LEAF 6 [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:62106-1150-8 1 in 1 CARTON 09/22/2015 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 09/22/2015 Labeler - Seroyal USA (018361118) Establishment Name Address ID/FEI Business Operations SAN’UP 401010287 manufacture(62106-1148, 62106-1150)