Throat Balm Caramel Pectin: Package Insert and Label Information

THROAT BALM CARAMEL PECTIN- pectin lozenge
Ricola USA Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient (in two drops)

Pectin 7.6 mg

Purpose

Oral demulcent

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: 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

THROAT BALM CARAMEL PECTIN pectin lozenge

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63667-301 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PECTIN (PECTIN) PECTIN 3.8 mg

Inactive Ingredients Ingredient Name Strength SUCROSE CARAMEL

Product Characteristics Color brown Score no score Shape OVAL Size 24mm Flavor CARAMEL Imprint Code R Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:63667-301-34 34 LOZENGE in 1 BAG None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 11/01/2022

Labeler — Ricola USA Inc. (177265261)

Establishment
Name	Address	ID/FEI	Operations
Ricola Ag		485393768	manufacture (63667-301)

Revised: 01/2023 Ricola USA Inc.