Otc - Active Ingredient
Active ingredient (in two drops)
Pectin 7.6 mg
Throat Balm Caramel Pectin Lozenge
FDA Label NDC 54305-301
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 Ag for the product Throat Balm Caramel Pectin (NDC 54305-301). 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, indications & usage, warnings, otc - ask doctor, otc - keep out of reach of children, dosage & administration, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Oral demulcent
Indications & Usage
Uses temporarily relieves:
occasional minor irritation and pain associated with
- sore mouth
- sore throat
Warnings
Warnings
Do not use
- in children under 6 years of age unless directed by a doctor.
Otc - Ask 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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
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
Storage And Handling
Other Information
protect from heat and moisture
Inactive Ingredient
Inactive Ingredients: Caramel sugar syrup; cocoa butter; emulsifier (sunflower lecithin), extracts of bee balm, Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme) and rooibos; glucose syrup; glucose-fructose syrup; honey; humectant (glycerine); natural flavoring (caramel, echinacea purpurea fresh plant pressed juice powder, honey, menthol, peppermint, vanilla); salt; sugar
Package Label.Principal Display Panel
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