Sootheez Watermelon Mint

Manufacturer
Primrose Candy Co.
Effective date
2026-03-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:52:17

Label at a glance#

ProductSootheez Watermelon Mint
Active ingredientPECTIN
Label structure8 sections

Indications and uses

Uses for temporary relief of minor discomfort of the throat.

Dosage and administration

Adukts and children 10 years of age and older: allow one drop to dissolve slowly in mouth May be repeated as needed or as directed by a doctor Children under 10 years of age: ask a doctor

Storage and handling

store in a dry place between 65-75F with in sealed.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pectin 11.5mg

Purpose

OTC - PURPOSE SECTION

Oral Demulcent

Uses

INDICATIONS & USAGE SECTION

Uses for temporary relief of minor discomfort of the 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, nuasea, or vomiting, consult a doctor promptly. If sore mouth symptoms, do not improve in 7 days, see your denist or doctor promptly.

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if:

  • sore throat 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

Keep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adukts and children 10 years of age and older: allow one drop to dissolve slowly in mouth
  • May be repeated as needed or as directed by a doctor
  • Children under 10 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

store in a dry place between 65-75F with in sealed.

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid

organic apple juice concentrate

organic cane sugar

organic grape juice concentrate

organic honey

organic mint flavor

organic raspberry powder

organic rice syrup

organic lemon juice concentrate

organic vegetable juice concentrate (carrot, radish)

organic watermelon flavor

organic wildberry juice concentrate

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2204565pectin 11.5 MG Throat PopPSN1
2204565pectin 11.5 MG Oral LozengeSCD1
2204565pectin 11.5 MG Throat PopSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61584-020-01Sootheez Watermelon Mint49 g in 1 CANISTERLOZENGE491

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61584-02061584-020-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

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
Sootheez Watermelon MintPECTINPrimrose Candy Co.4e5e4342-4647-ef25-e063-6394a90a1d132026-03-31WarningsExact identifier
ndc (package): 61584-020-01
ndc (product): 61584-020
ndc11 (package): 61584002001
spl id: 4e5e4342-4648-ef25-e063-6394a90a1d13
spl set id: 4e5e4342-4647-ef25-e063-6394a90a1d13

Reported adverse events (FAERS/openFDA)#

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