Label: UNDA 24- crataegus fruit, passiflora incarnata, boldo leaf, valeriana officinalis root, chamomilla, aluminium metallicum liquid
- NDC Code(s): 62106-1123-8
- 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
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- ASK DOCTOR
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
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INDICATIONS & USAGE
Uses
For the temporary relief of symptoms associated with mild digestive upset.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
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INGREDIENTS AND APPEARANCE
UNDA 24
crataegus fruit, passiflora incarnata, boldo leaf, valeriana officinalis root, chamomilla, aluminium metallicum liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62106-1123 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 CRATAEGUS FRUIT (UNII: Q21UUL2105) (CRATAEGUS FRUIT - UNII:Q21UUL2105) CRATAEGUS FRUIT 4 [hp_X] in 20 mL PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP 4 [hp_X] in 20 mL VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN 4 [hp_X] in 20 mL MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 4 [hp_X] in 20 mL ALUMINUM (UNII: CPD4NFA903) (ALUMINUM - UNII:CPD4NFA903) ALUMINUM 12 [hp_X] in 20 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62106-1123-8 1 in 1 CARTON 02/24/2015 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 02/24/2015 Labeler - Seroyal USA (018361118) Establishment Name Address ID/FEI Business Operations SAN’UP 401010287 manufacture(62106-1123)
