FDA.reportPublic FDA data

burts bees throat soothing

Manufacturer
L. Perrigo Company
Effective date
2024-07-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:58:29

Label at a glance#

Productburts bees throat soothing
Active ingredientPECTIN
Label structure9 sections

Indications and uses

• for temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat

Dosage and administration

• children 3 years and older: allow one throat pop to dissolve slowly in mouth, child should be seated and under adult supervision • may be repeated as needed or as directed by a doctor • children under 3 years: ask a doctor

Label contents#

Full prescribing information#

Active ingredient (in each throat pop)

OTC - ACTIVE INGREDIENT SECTION

Pectin 10.5 mg

Purpose

OTC - PURPOSE SECTION

Oral demulcent

Uses

INDICATIONS & USAGE SECTION

  • for temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat

Warnings

WARNINGS SECTION

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • sore mouth does not improve in 7 days
  • irritation, pain or redness persists or worsens

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • children 3 years and older: allow one throat pop to dissolve slowly in mouth, child should be seated and under adult supervision
  • may be repeated as needed or as directed by a doctor
  • children under 3 years: ask a doctor

Other information

OTHER SAFETY INFORMATION

  • store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, manuka honey, natural flavor, organic rice syrup, raspberry powder, sucrose, water

Questions or comments?

OTC - QUESTIONS SECTION

1-800-864-9649

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3 + YEARS

burt’s bees…KIDS…™

throat soothing pops

NOT ACTUAL SIZE

Oral Demulcent | Pectin 10.5 mg/pop

Helps Soothe Sore, Irritated Throats

Made with 100% Natural Manuka Honey

CHERRY

No Synthetic Colors or Flavors

NON-GMO

15 Throat Pops

throat soothing pops- image-1
throat soothing pops- image-1
throat soothing pops-image-2
throat soothing pops-image-2

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0113-80040113-8004-22, 0113-8004-46

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
PECTIN89NA02M4RXACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SUCROSEC151H8M554IACT
WATER059QF0KO0RIACT

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
795caccf-594a-4438-a8ff-07941e707aebb4ba13c4-6e9c-4a2c-926e-e4f0ecfc6ccc2024-07-23WarningsExact identifier
spl id: 795caccf-594a-4438-a8ff-07941e707aeb
spl set id: b4ba13c4-6e9c-4a2c-926e-e4f0ecfc6ccc

Reported adverse events (FAERS/openFDA)#

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