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NDC 17856-0732-01 Cepacol 15; 2.6 mg/1; mg/1 Details
Cepacol 15; 2.6 mg/1; mg/1
Cepacol is a ORAL LOZENGE in the HUMAN OTC DRUG category. It is labeled and distributed by ATLANTIC BIOLOGICALS CORP.. The primary component is BENZOCAINE; MENTHOL.
Product Information
| NDC | 17856-0732 |
|---|---|
| Product ID | 17856-0732_4e1fd22f-4112-4c6d-a707-27211ff2b814 |
| Associated GPIs | |
| GCN Sequence Number | 067736 |
| GCN Sequence Number Description | benzocaine/menthol LOZENGE 15MG-2.6MG MUCOUS MEM |
| HIC3 | H0A |
| HIC3 Description | LOCAL ANESTHETICS |
| GCN | 30355 |
| HICL Sequence Number | 001675 |
| HICL Sequence Number Description | BENZOCAINE/MENTHOL |
| Brand/Generic | Generic |
| Proprietary Name | Cepacol |
| Proprietary Name Suffix | Extra Strength Sore Throat honey lemon |
| Non-Proprietary Name | Benzocaine and Menthol |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LOZENGE |
| Route | ORAL |
| Active Ingredient Strength | 15; 2.6 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | BENZOCAINE; MENTHOL |
| Labeler Name | ATLANTIC BIOLOGICALS CORP. |
| 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 17856-0732-01 (17856073201)
| NDC Package Code | 17856-0732-1 |
|---|---|
| Billing NDC | 17856073201 |
| Package | 50 POUCH in 1 BOX (17856-0732-1) / 1 LOZENGE in 1 POUCH (17856-0732-2) |
| Marketing Start Date | 2022-09-14 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 08160ced-e19b-443e-ab16-0d3e4ae8a8ab Details
SPL UNCLASSIFIED SECTION
Uses
Warnings
METHEMOGLOBINEMIA WARNING
Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. 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 any 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, 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
INGREDIENTS AND APPEARANCE
| CEPACOL
EXTRA STRENGTH SORE THROAT HONEY LEMON
benzocaine and menthol lozenge |
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| Labeler - ATLANTIC BIOLOGICALS CORP. (047437707) |
| Registrant - ATLANTIC BIOLOGICALS CORP. (047437707) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| UNIT DOSE SOLUTIONS | 360804194 | REPACK(17856-0732) | |
Revised: 9/2022
Document Id: 4e1fd22f-4112-4c6d-a707-27211ff2b814
Set id: 08160ced-e19b-443e-ab16-0d3e4ae8a8ab
Version: 5
Effective Time: 20220914