SOOTHEEZ BIRTHDAY CAKE- pectin lozenge

Sootheez Birthday Cake by

Drug Labeling and Warnings

Sootheez Birthday Cake by is a Otc medication manufactured, distributed, or labeled by Primrose Candy Co.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Pectin 11.5mg

Purpose

Oral Demulcent

Uses

Uses for temporary relief of minor discomfort of the throat.

Warnings

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

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

Keep out of reach of children

Directions

• 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

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

Inactive ingredients

organic cane sugar

organic honey

organic rice syrup

organic natural flavors

Label

INGREDIENTS AND APPEARANCE

SOOTHEEZ BIRTHDAY CAKE 
pectin lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61584-019
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX)	PECTIN	11.5 mg  in 3.5 g

Inactive Ingredients
Ingredient Name	Strength
HONEY (UNII: Y9H1V576FH)
WHITE RICE (UNII: A195V20H7A)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	yellow	Score	score with uneven pieces
Shape	OVAL	Size	23mm
Flavor	VANILLA	Imprint Code	P
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61584-019-01	49 g in 1 CANISTER; Type 0: Not a Combination Product	02/02/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	02/02/2026

Labeler - Primrose Candy Co. (005086855)

Establishment
Name	Address	ID/FEI	Business Operations
Primrose Candy Co.		005086855	manufacture(61584-019)