Current label cautions
The label says product safety has not been determined, instructs users to keep it out of reach of children under 12 and includes the standard dietary-supplement disclaimer. The seller also advises showing the product to a doctor before use.
Ingredient-specific considerations
NCCIH notes that oral ginger can cause abdominal discomfort, heartburn, diarrhea and mouth or throat irritation in some people, and advises medication users to discuss herbal products with a health professional. NCCIH also notes that peppermint oil can cause heartburn, nausea, abdominal pain, dry mouth or allergic reactions.
Who should seek professional guidance first?
- People taking prescription or over-the-counter medication regularly.
- Anyone who is pregnant, trying to become pregnant or breastfeeding.
- People with chronic respiratory, gastrointestinal, cardiovascular, bleeding or allergy concerns.
- Anyone considering a supplement in place of prescribed treatment.
Side effects versus disease symptoms
New or worsening shortness of breath, chest pain, fainting, severe wheezing, blue lips, confusion or other urgent symptoms should not be treated as a supplement “adjustment.” Seek urgent medical care when symptoms may be serious.
Is Breathe FDA approved?
No. Dietary supplements are regulated differently from drugs and are not approved by FDA before sale in the same way prescription medicines are. A statement that a facility is FDA registered is not FDA approval of the product.
Manufacturing statements
The seller reports that Breathe is made in the United States in an FDA-registered/GMP-certified facility and describes the ingredients as plant-based, soy-free, dairy-free and non-GMO. Those are seller-reported statements, not independent testing performed by Breathe.
References & further reading
Sources below support the labeling, ingredient or respiratory background discussed here. Ingredient evidence is not proof that the finished Breathe formula is clinically proven.
- FDA — Questions and Answers on Dietary Supplements
- NCCIH — Ginger: Usefulness and Safety
- NCCIH — Peppermint Oil: Usefulness and Safety