OTC Medication Information: Throat Balm Caramel Pectin

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

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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.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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