THROAT BALM CARAMEL PECTIN- pectin lozenge

Throat Balm Caramel Pectin by

Drug Labeling and Warnings

Throat Balm Caramel Pectin by is a Otc medication manufactured, distributed, or labeled by Ricola USA Inc., Ricola Ag. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in two drops)

Pectin 7.6 mg

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.

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.

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

THROAT BALM CARAMEL PECTIN 
pectin lozenge

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX)	PECTIN	3.8 mg

Inactive Ingredients
Ingredient Name	Strength
SUCROSE CARAMEL (UNII: D8GMM4517Q)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63667-301-34	34 in 1 BAG; Type 0: Not a Combination Product	11/01/2022

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	Business Operations
Ricola Ag		485393768	manufacture(63667-301)