FDA.reportPublic FDA data

Throat Balm Caramel Pectin

Manufacturer
Ricola USA Inc. | Ricola Ag
Effective date
2024-12-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:41:32

Label at a glance#

ProductThroat Balm Caramel Pectin
Active ingredientPECTIN
Label structure10 sections

Storage and handling

Other Information protect from heat and moisture

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in two drops)

Pectin 7.6 mg

OTC - PURPOSE SECTION

Purpose

Oral demulcent

INDICATIONS & USAGE SECTION

Uses temporarily relieves:

occasional minor irritation and pain associated with

  • sore mouth
  • sore throat

WARNINGS SECTION

Warnings

Do not use

  • ​in children under 6 years of age unless directed by a doctor.

OTC - ASK DOCTOR SECTION

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 SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

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 SECTION

Other Information

protect from heat and moisture

INACTIVE INGREDIENT SECTION

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

Image of BT HERMELECH 34ct US 9014779 low.jpgImage of BT HERMELECH 34ct US 9014779 low.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2621646pectin 3.8 MG Oral LozengePSN3
2621646pectin 3.8 MG Oral LozengeSCD3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63667-301-34Throat Balm Caramel Pectin34 in 1 BAGLOZENGE343

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63667-301THROAT BALM CARAMEL PECTIN (PECTIN) LOZENGE [RICOLA USA INC.]3Current NDC, Legacy NDC, 1 package rows20241211_23cf2ba5-9d4d-409b-ab0e-a1d702f0bb15.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63667-30163667-301-34

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
PECTIN89NA02M4RXACTIB
SUCROSE CARAMELD8GMM4517QIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Throat Balm Caramel PectinPECTINRicola USA Inc.23cf2ba5-9d4d-409b-ab0e-a1d702f0bb152024-12-10WarningsExact identifier
ndc (package): 63667-301-34
ndc (product): 63667-301
ndc11 (package): 63667030134
spl id: cde7cc2b-f94e-410e-9941-1470bbd67358
spl set id: 23cf2ba5-9d4d-409b-ab0e-a1d702f0bb15

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.