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NDC 63736-0205-01 CEPASTAT 6; 5; 10 mg/1; mg/1; mg/1 Details
CEPASTAT 6; 5; 10 mg/1; mg/1; mg/1
CEPASTAT is a ORAL LOZENGE in the HUMAN OTC DRUG category. It is labeled and distributed by Insight Pharmaceuticals LLC. The primary component is BENZOCAINE; DEXTROMETHORPHAN HYDROBROMIDE; MENTHOL.
Product Information
| NDC | 63736-0205 |
|---|---|
| Product ID | 63736-205_c763b32e-91b7-4c97-baf5-f523f385a96e |
| 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 | CEPASTAT |
| Proprietary Name Suffix | Sore throat and Cough |
| Non-Proprietary Name | Benzocaine, Dextromethorphan HBr, Menthol |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LOZENGE |
| Route | ORAL |
| Active Ingredient Strength | 6; 5; 10 |
| Active Ingredient Units | mg/1; mg/1; mg/1 |
| Substance Name | BENZOCAINE; DEXTROMETHORPHAN HYDROBROMIDE; MENTHOL |
| Labeler Name | Insight Pharmaceuticals LLC |
| 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 | 2024-12-31 |
Package
Package Images
NDC 63736-0205-01 (63736020501)
| NDC Package Code | 63736-205-01 |
|---|---|
| Billing NDC | 63736020501 |
| Package | 3 BLISTER PACK in 1 CARTON (63736-205-01) / 6 LOZENGE in 1 BLISTER PACK |
| Marketing Start Date | 2016-10-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 93f0e60f-4dda-4ec9-b391-e059a0876654 Details
SPL UNCLASSIFIED SECTION
Uses
Warnings
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: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 6 years of age unless directed by a doctor.
Do not use
- this product 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 are uncertain whether your prescription drug contains an MAOI, consult a health care professional before taking this product.
- this product for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
Stop use and ask a dentist or doctor if
- sore mouth symptoms do not improve in 7 days
- irritation, pain or redness persists or worsens
- swelling, rash or fever develops
- cough persists for more than 1 week, tends to recur, or is accompanied by a high fever, rash, or persistent headache. These could be symptoms of a serious condition.
Directions
Other information
Inactive ingredients
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| CEPASTAT
SORE THROAT AND COUGH
benzocaine, dextromethorphan hbr, menthol lozenge |
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| Labeler - Insight Pharmaceuticals LLC (055665422) |
Revised: 3/2017
Document Id: c763b32e-91b7-4c97-baf5-f523f385a96e
Set id: 93f0e60f-4dda-4ec9-b391-e059a0876654
Version: 2
Effective Time: 20170310