Anesthetic Lozenges Honey Lime Flavors
FDA Label NDC 83348-002

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Prason Foods for the product Anesthetic Lozenges Honey Lime Flavors (NDC 83348-002). 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, warning, directions, other information, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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, Citric acid, Honey lime flavor, Liquid glucose, Sucrose, Tartaric acid, Tartrazine and Water

Product Label

Image Description (Updated Label Honeylime 2)

Image Description (Updated Label Honeylime 2)

Image Description (Updated Label Honeylime)

Image Description (Updated Label Honeylime)

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