The following Structured Product Label (SPL) was submitted to the FDA by Seroyal Usa for the product Unda 245 (NDC 62106-1163). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, overdosage, inactive ingredient, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients
Each drop contains:
Fagopyrum esculentum (Buckwheat) Aerial Parts 4X
Pulsatilla (Wind flower) Whole Plant 4X
Rheum (Chinese rhubarb) Underground Parts 4X
Thuja occidentalis (White cedar) Twig 4X
Viburnum prunifolium (Blackhaw) Bark 4X
Uses
For the temporary relief of symptoms associated with minor menstrual pains.
Warnings
Stop use and ask a doctor if symptoms
persist or worsen.
If pregnant or breastfeeding, ask a
health professional before use.
Keep out of reach of children. In case
of overdose, get medical help or contact
a Poison Control Center right away.
If pregnant or breastfeeding, ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a
Poison Control Center right away.
Inactive ingredients
Ethanol (beet), purified water
Other information
Do not use if seal is missing or broken.
Store in a cool, dry place.
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.
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.
NDC 62106-1163-8
UNDA
numbered compounds
UNDA 245
Homeopathic Preparation
For the temporary relief of symptoms
associated with minor menstrual pains.
Contains 32% Alcohol
0.7 fl oz (20 mL)
* Please review the disclaimer below.
