The following Structured Product Label (SPL) was submitted to the FDA by Progresyvus Tyrimai Mb for the product Spirudio (NDC 87754-0001). 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 dosage & administration, warnings, inactive ingredient, indications & usage, otc - keep out of reach of children, otc - purpose, otc - active ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Directions:
Dissolve 1 tablet, three times daily under the tongue. For stronger effects, take 2 tablets, up to three times daily. Use regularly for best results.
Description
Spirudio For Children is a gentle formula designed to support kids’ focus, calmness, and overall emotional balance. Safe and effective for children ages 5 and up, it works with the body to promote clarity and reduce everyday stress without harsh stimulants.
If pregnant or breastfeeding, ask a healthcare professional before use. If symptoms persist or worsen, discontinue use and consult a healthcare professional. Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. Consult a physician before use if you have a medical condition or are taking any medication. This product is not intended to diagnose, treat, cure, or prevent any disease.
Inactive: Lactose monohydrate, microcrystalline cellulose, magnesium stearate.
Directions:
Dissolve 1 tablet, three times daily under the tongue. For stronger effects, up to 2 tablets, three times daily may be taken. Use regularly for best results.
keep out of reach of children
May help enhance:
Mental clarity
Concentration and attention
Emotional stability
May help reduce:
Feelings of anxiety and stress
Restlessness and irritability
Impulsivity and emotional reactivity
This natural formula may help you feel calmer, more focused, and better equipped to handle the demands of everyday life while supporting long-term mental well-being.
Active: Targeted antibodies to S100 protein (helps regulate mood, focus, and stress response).
Adults
Description
Spirudio For Adults is a gentle, non-habit forming formula designed to help manage stress, improve focus, and support emotional balance in daily life. Safe for adults 18 years and older, it works with the body to promote calmness, mental clarity, and resilience without harsh stimulants or sedatives.
May help enhance:
Mental clarity
Concentration and attention
Emotional stability
May help reduce:
Feelings of anxiety and stress
Restlessness and irritability
Impulsivity and emotional reactivity
This natural formula may help you feel calmer, more focused, and better equipped to handle the demands of everyday life while supporting long-term mental well-being.
Directions:
Dissolve 1 tablet, three times daily under the tongue. For stronger effects, take 2 tablets, up to three times daily. Use regularly for best results.
Ingredients:
Active: Targeted antibodies to S100 protein (supports regulation of mood, focus, and stress response).
Inactive: Lactose monohydrate, microcrystalline cellulose, magnesium stearate.
No artificial colors
No artificial flavors
Gluten-free & nut-free
For Adults (18 years and older).
Non-drowsy, non-habit forming.
Children
Description
Spirudio For Children is a gentle formula designed to support kids’ focus, calmness, and overall emotional balance. Safe and effective for children ages 5 and up, it works with the body to promote clarity and reduce everyday stress without harsh stimulants.
May help enhance:
Mental clarity
Concentration and attention
Emotional balance
May help reduce:
Feelings of anxiety and stress
Restlessness and hyperactivity
Irritability and impulsivity
A natural and non-habit forming formula that may help children feel calmer, more focused, and better equipped to handle everyday challenges.
Directions:
Dissolve 1 tablet, three times daily under the tongue. For stronger effects, up to 2 tablets, three times daily may be taken. Use regularly for best results.
Ingredients:
Active: Targeted antibodies to S100 protein (helps regulate mood, focus, and stress response).
Inactive: Lactose monohydrate, microcrystalline cellulose, magnesium stearate.
No artificial colors
No artificial flavors
Gluten-free & nut-free
For children ages 5 and up.
Non-drowsy, non-habit forming.
Carton Label Image 2 (Spirudio2)
Carton Label Image 3 (Spirudio3)
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