- SPL UNCLASSIFIED SECTION
- Active ingredient (in each lozenge)
- Purpose
- Uses
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Warnings
Methemoglobinemia warning
Use of this product may cause methemoglobinemia, a serious condition that must be treated 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)
- shortness of breath
- headache
- dizziness or lightheadedness
- rapid heart rate
- fatigue or lack of energy
Allergy Alert
Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or any other "caine" anesthetics. If skin reaction occurs, stop use and seek medical help right away.
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.
- Directions
- Other information
- Inactive ingredients
- Questions
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 18 Lozenge Blister Pack Box
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INGREDIENTS AND APPEARANCE
BACTIMICINA FOR SORE THROAT
benzocaine lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24286-1572 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength benzocaine (UNII: U3RSY48JW5) (benzocaine - UNII:U3RSY48JW5) benzocaine 15 mg Inactive Ingredients Ingredient Name Strength Corn Syrup (UNII: 9G5L16BK6N) FD&C Yellow No. 6 (UNII: H77VEI93A8) Glycerin (UNII: PDC6A3C0OX) Sucrose (UNII: C151H8M554) Product Characteristics Color ORANGE Score no score Shape OVAL Size 20mm Flavor ORANGE Imprint Code P Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24286-1572-1 3 in 1 BOX 01/30/2013 1 6 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 01/30/2013 Labeler - DLC Laboratories, Inc. (093351930)