FDA Label for Throat Balm Caramel Pectin
View Indications, Usage & Precautions
Throat Balm Caramel Pectin Product Label
The following document was submitted to the FDA by the labeler of this product Ricola Ag. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredient (in two drops)
Pectin 7.6 mg
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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