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NDC 41163-0021-18 mixed berry sore throat and cough lozenge 7.5; 5 mg/1; mg/1 Details
mixed berry sore throat and cough lozenge 7.5; 5 mg/1; mg/1
mixed berry sore throat and cough lozenge is a ORAL LOZENGE in the HUMAN OTC DRUG category. It is labeled and distributed by Super Valu. The primary component is BENZOCAINE; DEXTROMETHORPHAN HYDROBROMIDE.
Product Information
NDC | 41163-0021 |
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Product ID | 41163-021_ed9bd594-8a84-d7e6-e053-2995a90af92a |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | mixed berry sore throat and cough lozenge |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | benzocaine |
Product Type | HUMAN OTC DRUG |
Dosage Form | LOZENGE |
Route | ORAL |
Active Ingredient Strength | 7.5; 5 |
Active Ingredient Units | mg/1; mg/1 |
Substance Name | BENZOCAINE; DEXTROMETHORPHAN HYDROBROMIDE |
Labeler Name | Super Valu |
Pharmaceutical Class | Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Standardized Chemical Allergen [EPC], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA R |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH NOT FINAL |
Application Number | part356 |
Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 41163-0021-18 (41163002118)
NDC Package Code | 41163-021-18 |
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Billing NDC | 41163002118 |
Package | 18 LOZENGE in 1 BLISTER PACK (41163-021-18) |
Marketing Start Date | 2015-10-16 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 44aaccba-036e-63dc-e054-00144ff8d46c Details
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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)
- headache
- rapid heart rate
- shortness of breath
- dizziness or lightheadedness
- fatigue or lack of energy
Sore throat warnings: 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.
SPL UNCLASSIFIED SECTION
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 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 contains an MAOI, as a doctor or pharmacist before taking this product.
- for teething
- in children under 2 years of age
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Directions
adults and children 12 years and older - allow 2 lozenges to dissolve 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
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
MIXED BERRY SORE THROAT AND COUGH LOZENGE
benzocaine lozenge |
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Labeler - Super Valu (006961411) |
Registrant - Bestco Inc. (002149136) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Bestco Inc. | 002149136 | manufacture(41163-021) |