Drugplain

Sootheez Birthday Cake 11.5 mg/3.5g

Pectin · LOZENGE · Primrose Candy Co.

No Recall History
Plain English

Sootheez Birthday Cake is an over-the-counter lozenge containing pectin that you dissolve in your mouth to help soothe throat discomfort. Pectin is a natural substance that coats the throat to provide temporary relief from minor irritation.

Key Facts

Brand Name
Sootheez Birthday Cake
Generic Name
Pectin
NDC Code (Product)
61584-019
Manufacturer
Primrose Candy Co.
Strength
11.5 mg/3.5g
Dosage Form
LOZENGE
Route
ORAL
Marketing Status
Application #
M022
Marketing Start
02/02/2026

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fatigue12 reports
abdominal pain7 reports
cough7 reports
nausea7 reports
diarrhoea6 reports
headache6 reports
pyrexia6 reports
anxiety5 reports
asthenia5 reports
malaise5 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Uses for temporary relief of minor discomfort of the throat.

Dosage & Administration

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

Warnings

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

Frequently Asked Questions

What is Sootheez Birthday Cake used for?

Sootheez Birthday Cake is an over-the-counter lozenge containing pectin that you dissolve in your mouth to help soothe throat discomfort. Pectin is a natural substance that coats the throat to provide temporary relief from minor irritation.

Is Sootheez Birthday Cake a controlled substance?

Sootheez Birthday Cake is not classified as a controlled substance by the DEA.

What is the generic name for Sootheez Birthday Cake?

The generic name for Sootheez Birthday Cake is Pectin. There are 11 other brand versions of Pectin.

What is the NDC code for Sootheez Birthday Cake 11.5 mg/3.5g?

The NDC (National Drug Code) for Sootheez Birthday Cake 11.5 mg/3.5g is 61584-019, listed by Primrose Candy Co..

Product NDC

61584-019

Package NDC

61584-019-01

Other Pectin Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)