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NDC 63824-0715-36 Cepacol Extra Strength Sore Throat Cherry 15; 3.6 mg/1; mg/1 Details
Cepacol Extra Strength Sore Throat Cherry 15; 3.6 mg/1; mg/1
Cepacol Extra Strength Sore Throat Cherry is a ORAL LOZENGE in the HUMAN OTC DRUG category. It is labeled and distributed by RB Health (US) LLC. The primary component is BENZOCAINE; MENTHOL, UNSPECIFIED FORM.
Product Information
| NDC | 63824-0715 |
|---|---|
| Product ID | 63824-715_4a47a616-4325-4167-acd6-c43bf798bef2 |
| Associated GPIs | 88359902154795 |
| GCN Sequence Number | 067735 |
| GCN Sequence Number Description | benzocaine/menthol LOZENGE 15MG-3.6MG MUCOUS MEM |
| HIC3 | H0A |
| HIC3 Description | LOCAL ANESTHETICS |
| GCN | 30354 |
| HICL Sequence Number | 001675 |
| HICL Sequence Number Description | BENZOCAINE/MENTHOL |
| Brand/Generic | Brand |
| Proprietary Name | Cepacol Extra Strength Sore Throat Cherry |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Benzocaine and Menthol, Unspecified Form |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LOZENGE |
| Route | ORAL |
| Active Ingredient Strength | 15; 3.6 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | BENZOCAINE; MENTHOL, UNSPECIFIED FORM |
| Labeler Name | RB Health (US) LLC |
| Pharmaceutical Class | Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part356 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 63824-0715-36 (63824071536)
| NDC Package Code | 63824-715-36 |
|---|---|
| Billing NDC | 63824071536 |
| Package | 3 BLISTER PACK in 1 CARTON (63824-715-36) / 12 LOZENGE in 1 BLISTER PACK |
| Marketing Start Date | 2019-05-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 94165dc9-ea46-4ab9-bdec-674e072b5ad5 Details
SPL UNCLASSIFIED SECTION
Uses
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
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.
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.
Stop use and ask a doctor or dentist if
- sore mouth symptoms do not improve in 7 days
- irritation, pain, or redness persists or worsens
- swelling, rash, or fever develops
Directions
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 16 Lozenge Blister Pack Carton
INGREDIENTS AND APPEARANCE
| CEPACOL EXTRA STRENGTH SORE THROAT CHERRY
benzocaine and menthol, unspecified form lozenge |
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| Labeler - RB Health (US) LLC (081049410) |
Revised: 1/2022
Document Id: 4a47a616-4325-4167-acd6-c43bf798bef2
Set id: 94165dc9-ea46-4ab9-bdec-674e072b5ad5
Version: 4
Effective Time: 20220120