NDC | 62106-1123-8 |
Set ID | 0fd99c06-1ea8-7171-e054-00144ff8d46c |
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
- 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)