Lozenge
CEPASTAT Sore throat and Cough
Menthol 10 mg, Benzocaine 6 mg, Dextromethorphan Hydrobromide 5 mg
Over the counterMonograph M022
The listing
- NDC product code
- 63736-205 (labeller 63736, product 205)
- Labeller
- Insight Pharmaceuticals LLC
- Brand name
- CEPASTAT Sore throat and Cough
- Generic name
- Benzocaine, Dextromethorphan HBr, Menthol
- Dosage form
- Lozenge
- Route
- oral
- Marketing category
- OTC MONOGRAPH DRUG M022
- Marketing start
- 1 October 2016
- Listing expires
- 31 December 2026
- Pharmacologic class
- Standardized Chemical Allergen [EPC]
- RxNorm concept
- 1045532
Active ingredients
| Ingredient | Strength | Other listings |
|---|---|---|
| Menthol | 10 mg | 460 |
| Benzocaine | 6 mg | 35 |
| Dextromethorphan Hydrobromide | 5 mg | 15 |
Strengths as listed in the FDA National Drug Code Directory, retrieved 4 September 2026. "Other listings" counts every other product on this site containing the same ingredient at any strength.
What the label claims
These are read from this product's own label, not assigned by us and not inferred from the ingredient.
Stated purposeCough suppressantOral anesthetic
Stated useSore throatMinor throat irritationCoughSore mouth, gums and canker soresCommon cold symptoms
Drug Facts, as filed
Quoted from the label FDA holds for this product. Long fields are truncated. The panel printed on the package you are holding is the one that governs.
- Active ingredient
- (in each lozenge) Benzocaine 6 mg Active Ingredients (in each lozenge) Dextromethorphan HBr 5 mg Active Ingredients (in each lozenge) Menthol 10 mg
- Purpose
- Oral Anesthetic/Analgesic Purpose Cough Suppressant Purpose Oral Anesthetic/Analgesic
- Uses
- Temporarily relieves occasional minor irritation, pain, sore throat and sore mouth cough due to minor throat and bronchial irritation as may occur with the common cold
- 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. When using this product do not exceed recommended dosage. 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...
- Ask a doctor before use
- 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.
- If pregnant or breast-feeding
- If pregnant or breast-feeding, ask a health care professional before use.
- Keep out of reach of children
- Keep out of reach of children. In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center right away.
- Directions
- Adults and children over 12 years of age: 2 lozenges every 4 hours - not to exceed 12 lozenges every 24 hours. Children 6-12 years of age: 1 lozenge every 4 hours - not to exceed 6 lozenges every 24 hours. Children under 6 years of age: consult a doctor.
- Inactive ingredients
- acesulfame potassium, FD&C blue no. 1, FD&C red no. 40, flavor, glycerine, hydrogenated starch hydrolysate, isomalt, soy lecithin, sucralose, water
- Other information
- 1-800-552-7932
Label version 3, effective 25 October 2024. Retrieved from the openFDA drug label API on 4 September 2026. Read the full label on DailyMed.
Packages
| Package NDC | Description | Listed from |
|---|---|---|
| 63736-205-01 | 3 BLISTER PACK in 1 CARTON (63736-205-01) / 6 LOZENGE in 1 BLISTER PACK | 1 October 2016 |
The package NDC adds a third segment to the product code, identifying the pack size. See how to read an NDC.
Identical on the active ingredient
3 other listings state exactly the same active ingredient at exactly the same strength in the same dosage form, across 2 different labellers. They are not necessarily the same product: inactive ingredients, flavour and pack size differ, and this site does not compare prices.
| Product | Labeller | NDC |
|---|---|---|
| Chloraseptic Total Sore Throat and Cough | Prestige Brands Holdings, Inc. | 67172-016 |
| Chloraseptic Total Sore Throat and Cough, Sugar Free | Prestige Brands Holdings, Inc. | 67172-015 |
| Diabetic Tussin Sore Throat and Cough Cherry | MEDTECH PRODUCTS INC | 61787-070 |
Sources for this page
Lozenges.com is a reference publication built from FDA product listings and drug labels. It is not medical advice, diagnosis or treatment, it does not recommend any product for any condition, and it is not a substitute for a pharmacist or a doctor.