Label: CHERRY SORE THROAT LOZENGE- benzocaine lozenge
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- NDC Code(s): 0363-1079-18
- Packager: Walgreens Co.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 28, 2022
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- ACTIVE INGREDIENT
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- INDICATIONS & USAGE
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WARNINGS
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 attension if you or a child in your care develops:
- pale, gray, or blue colored skin (cyanosis)
- headache
- rapid heart rate
- shortness of breath
- dizziness or lightheadedness
- fatigue or lack of energy
Sore throat warning: If sore throat is severe, persistent 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 persists or worsens, see your dentist or doctor promptly.
Allergy alert: Do not use this product if you have a history of allergy to local anesthethics such as procaine, butacine, benzocaine, or other "caine" anesthetics.
- DO NOT USE
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CHERRY SORE THROAT LOZENGE
benzocaine lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-1079 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 15 mg MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 3.6 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Product Characteristics Color red Score score with uneven pieces Shape ROUND Size 17mm Flavor CHERRY Imprint Code B Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-1079-18 18 in 1 BLISTER PACK; Type 0: Not a Combination Product 04/15/2016 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 04/15/2016 Labeler - Walgreens Co. (008965063) Registrant - BestCo Inc. (002149136) Establishment Name Address ID/FEI Business Operations BestCo Inc. 002149136 manufacture(0363-1079)
