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  5. Label Information: Anesthetic Lozenges Raspberry Flavour

FDA Label for Anesthetic Lozenges Raspberry Flavour

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNING
    5. DIRECTIONS
    6. OTHER INFORMATION
    7. INACTIVE INGREDIENTS
    8. PRODUCT LABEL

Anesthetic Lozenges Raspberry Flavour Product Label

The following document was submitted to the FDA by the labeler of this product Prason Foods. 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 Ingredient



Benzocaine   15 mg

Menthol        2.6 mg


Purpose



Oral anesthetic


Uses



Temporarily relieves occasional minor irritation, pain, sore throat and sore mouth.


Warning



Methemoglobinemia warning
Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduced 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, grey, or blue colored skin (Cyanosis)
  • Headache
  • Rapid heart ache
  • Shortness of breath
  • Dizziness or light headedness
  • Fatigue or lack of energy

    • 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.

    Do not use

    • For teething
    • In children under 5 years of age

      • Stop use and ask doctor if

      • Sore mouth symptoms do not improve in 7 days.


        • If pregnant or breast-feeding, ask a health professional before use.


        Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away.

        Allergy alert : Do not use this product if you have a history of allergy to local anesthetic such as procaine, butacaine, benzocaine, or other "caine" anesthetics


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.


Other Information



  • Store at room temperature
  • Protect from moisture.

    • TEMPER EVIDENT PACKAGING. DO NOT USE IF OUTER BOX OR BLISTER IS OPENED OR DAMAGED.


Inactive Ingredients



Acesulfame k, Allura Red AC (FD & Red No.40), Citric acid, Liquid glucose, Raspberry flavor, Sucrose, Tartaric acid and Water


Product Label



image description - Updated Label 2

image description - Updated Label 2


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