Label: MIXED BERRY SORE THROAT AND COUGH LOZENGE- benzocaine lozenge
- NDC Code(s): 0363-1080-18
- Packager: Walgreen Company
- 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.
Updated December 15, 2021
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
Use of this product may cause methemoglobinemia, a serious conditin 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 of you or a child in your care develops:
- pale, gray, or blue colored skin (cyanosis)
- rapid heart rate
- shortness of breath
- dizziness or lightheadedness
- 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 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 anesthetics such as procaine, butacaine, benzocaine, or other "caine: anesthetics.
DO NOT USE
Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug is an MAOI, ask a doctor or pharmacist before taking this product.
- for teething
- in children under 2 years of age
- ASK DOCTOR
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
DOSAGE & ADMINISTRATION
adults and children 12 years and older - allow 2 lozenges to dissolve slowly in mouth, one at a time; may be repeated every 4 hours, not to exceed 12 lozenges in 24 hours, or as directed by a doctor
children 6 to 12 years of age - take 1 lozenge and allow to dissolve slowly in the mouth; may be repeated every 4 hours, not to exceed 6 lozenges in 24 hours, or as directed by a doctor
children under 6 years of age - do not use
- INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
MIXED BERRY SORE THROAT AND COUGH LOZENGE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-1080 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 7.5 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 5 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Product Characteristics Color red Score no score Shape ROUND Size 17mm Flavor BERRY Imprint Code B Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-1080-18 18 in 1 BLISTER PACK; Type 0: Not a Combination Product 01/19/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 01/19/2016 Labeler - Walgreen Company (008965063) Registrant - Bestco Inc. (002149136) Establishment Name Address ID/FEI Business Operations Bestco Inc. 002149136 manufacture(0363-1080)