Active Ingredient
Pectin 11.5mg
Sootheez Birthday Cake Lozenge
FDA Label NDC 61584-019
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Primrose Candy Co. for the product Sootheez Birthday Cake (NDC 61584-019). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, stop use and ask a doctor if, keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
* Please review the disclaimer below.
