FDA Label for Angidol Raspberry
View Indications, Usage & Precautions
Angidol Raspberry Product Label
The following document was submitted to the FDA by the labeler of this product Grandall Distributing, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients
BENZOCAINE 15MG
MENTHOL 2.6MG
Purpose
ORAL ANESTHETIC
Uses
Temporarily relieves these symptoms:
- occasional minor irritation, pain, sore mouth and sore throat
Warnings
Methemogoblinemia warning:
Use of this product may cause methemoglobinemia, a serious condition that must be treate promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:
- Pale, gray, or blue colored skin (cyanosis)
- headache
- rapid heart ache
- shortness of breath
- dizziness or light-headedness
- fatigue or lack of energy
- for teething
- in children under 2 years of age
- sore throat is severe or irritation, pain or redness persists or worsens
- sore mouth symptoms do not improve in 7 days
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied, or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or if irritation, pain or redness persist or worsens, see your dentist or doctor promptly. Allergy alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other “caine” anesthetics.
Do not use
Stop use and ask doctor if
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away.
Directions
adults and children 5 years and older: allow 1 lozenge to dissolve slowly in mouth. May be repeated every two hours as necessary or as directed by a doctor
children under 5 years: do not use
Inactive Ingredients
RASPBERRY FLAVOR: Liquid Glucose, Sucrose, Acesulfame K, Tartaric acid, Citric acid, Carmoisine, Raspberry flavour and water.
Questions?
Call 1-515-276-1586, Monday through Friday, 9AM - 4PM EST
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