Sootheez Birthday Cake

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 Birthday Cake

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

organic cane sugar

organic honey

organic rice syrup

organic natural flavors

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
2204565	pectin 11.5 MG Throat Pop	PSN	1
2204565	pectin 11.5 MG Oral Lozenge	SCD	1
2204565	pectin 11.5 MG Throat Pop	SY	1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61584-019-01	Sootheez Birthday Cake	49 g in 1 CANISTER	LOZENGE	49		1

Products#

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

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

Sootheez Birthday Cake
Pectin
HONEY
WHITE RICE
SUCROSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
61584-019	61584-019-01

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
Name	UNII	Kind
HONEY	Y9H1V576FH	IACT
WHITE RICE	A195V20H7A	IACT
PECTIN	89NA02M4RX	ACTIB
SUCROSE	C151H8M554	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sootheez Birthday Cake	PECTIN	Primrose Candy Co.	4e5d8234-0521-0c8a-e063-6294a90ae62d	2026-03-31	Warnings	Exact identifier ndc (package): 61584-019-01 ndc (product): 61584-019 ndc11 (package): 61584001901 spl id: 4e5d8234-0520-0c8a-e063-6294a90ae62d spl set id: 4e5d8234-0521-0c8a-e063-6294a90ae62d

Reported adverse events (FAERS/openFDA)#

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