The following Structured Product Label (SPL) was submitted to the FDA by Seroyal Usa for the product Unda 240 (NDC 62106-1161). 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 - keep out of reach of children, otc - pregnancy or breast feeding, other safety information, inactive ingredient, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients
Each drop contains:
Equisetum arvense (Common horsetail) Stem 6X
Gentiana lutea (Yellow gentian) Underground Parts 6X
Salvia officinalis (Garden sage) Leaf 6X
Saxifraga granulata Aerial Parts 6X
Spiraea ulmaria (Queen-of-themeadow) Underground Parts 6X
Uses
For the temporary relief of symptoms associated with growing 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.
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.
Other information
Do not use if seal is missing or broken.
Store in a cool, dry place.
Inactive ingredients
Ethanol (beet), purified water
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 growing 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 62106-1161-8
UNDA
numbered compounds
UNDA 240
Homeopathic Preparation
For the temporary relief of symptoms associated with growing pains.
Contains 31% Alcohol
0.7 fl oz (20 ml)
* Please review the disclaimer below.
