The following Structured Product Label (SPL) was submitted to the FDA by Seroyal Usa for the product Unda 32 (NDC 62106-1131). 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 - ask doctor, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients
Each drop contains:
Aconitum napellus (Aconite) Whole Plant 4X
Argentum metallicum (Silver) 12X
Borago officinalis (Common borage) Leaf 4X
Camphora (Camphor from Cinnamomum camphora) 4X
Grindelia Aerial Parts 4X
Stannum metallicum (Tin) 12X
Uses
For the temporary relief of cough.
Warnings
Ask a doctor before use if you have
Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.
Cough that is accompanied by excessive phlegm (mucus) or fever.
Stop use and ask a doctor if
Cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A
persistent cough may be a sign of a serious condition.
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.
Ask a doctor before use if you have
Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.
Cough that is accompanied by excessive phlegm (mucus) or fever.
Stop use and ask a doctor if
Cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
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.
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 cough.
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 62106-1131-8
UNDA
numbered compounds
UNDA 32
Homeopathic Preparation
For the temporary relief of cough.
Contains 31% Alcohol
0.7 fl oz (20 ml)
* Please review the disclaimer below.
