Label: UNDA 245- rheum, viburnum prunifolium, thuja occidentalis, pulsatilla, fagopyrum esculentum liquid
- NDC Code(s): 62106-1163-8
- 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
- INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
- DOSAGE & ADMINISTRATION
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INDICATIONS & USAGE
Uses
For the temporary relief of symptoms associated with minor menstrual pains.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 245
rheum, viburnum prunifolium, thuja occidentalis, pulsatilla, fagopyrum esculentum liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62106-1163 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RHEUM TANGUTICUM WHOLE (UNII: QH89N6B02U) (RHEUM TANGUTICUM WHOLE - UNII:QH89N6B02U) RHEUM TANGUTICUM WHOLE 4 [hp_X] in 20 mL VIBURNUM PRUNIFOLIUM BARK (UNII: J411UTU0HN) (VIBURNUM PRUNIFOLIUM BARK - UNII:J411UTU0HN) VIBURNUM PRUNIFOLIUM BARK 4 [hp_X] in 20 mL THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG 4 [hp_X] in 20 mL PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS 4 [hp_X] in 20 mL FAGOPYRUM ESCULENTUM (UNII: B10M69172N) (FAGOPYRUM ESCULENTUM - UNII:B10M69172N) FAGOPYRUM ESCULENTUM 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:62106-1163-8 1 in 1 CARTON 01/19/2015 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 01/19/2015 Labeler - Seroyal USA (018361118) Establishment Name Address ID/FEI Business Operations SAN’UP 401010287 manufacture(62106-1163)
