Drug Facts
Purpose
Oral anesthetic
Organic Peppermint Herb Throat Drops Lozenge
FDA Label NDC 63667-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ricola Usa Inc. for the product Organic Peppermint Herb Throat Drops (NDC 63667-010). 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 drug facts, active ingredient (in each drop), uses, warnings, stop use and ask a doctor if, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Drop)
Menthol, 1.9 mg
Uses
temporarily relieves occasional minor irritation and pain associated with:
- sore mouth
- sore throat
Warnings
Do not use
- in children under 6 years of age unless directed by a doctor.
Stop Use And Ask A Doctor If
- sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea or vomiting.
- sore mouth symptoms do not improve in 7 days.
Keep Out Of Reach Of Children.
Directions
- adults and children 6 years and older: dissolve 2 drops (one at a time) slowly in the mouth. Do not bite or chew. Repeat every 2 hours as needed or as directed by a doctor
- children under 6 years: ask a doctor
Other Information
protect from heat and moisture
Inactive Ingredients
extracts of peppermint and a Ricola herb mixture (ribwort plantain, lady's mantle, mallow, thyme, pimpinella, marshmallow, peppermint), peppermint oil, starch syrup, sugar
Package Label.Principal Display Panel
Image Of Bio_knospe_pfemi_54g.jpg (Bio Knospe Pfemi 54g)
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