Cepacol Sore Throat by Reckitt Benckiser LLC
Dosage form: lozenge
Ingredients: Benzocaine 15mg, Menthol 3.6mg
Labeler: Reckitt Benckiser LLC
NDC Code: 63824-721
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
|Active ingredients (in each lozenge)||Purpose|
|Benzocaine 15 mg||Oral pain reliever|
|Menthol 3.6 mg||Oral pain reliever|
temporary relief of occasional
- sore throat
- sore mouth
- minor mouth irritation
- pain associated with canker sores
- 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.
- 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.
Do not use in a child under 5 years of age.
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
If pregnant or breast-feeding, ask a health professional before use.
Keep this and all drugs out of the reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Do not exceed recommended dosage.
- adults and children 5 years or older: allow lozenge to dissolve slowly in the mouth; may be repeated every 2 hours as needed or as directed by a doctor or dentist.
- children under 5 years of age: do not use
- tamper evident: product is sealed in blister package for your protection. Do not use if carton is damaged or if printed seal on blister is broken or missing.
- store at room temperature 20-25°C (68-77°F)
- protect contents from humidity
D&C red #33, FD&C red #40, flavors, isomalt, maltitol, propylene glycol, purified water, sodium bicarbonate, sucralose
You may also report side effects to this phone number.
benzocaine and menthol lozenge
|Labeler - Reckitt Benckiser LLC (094405024)|
Medically reviewed on Dec 19, 2017
More about Cepacol Sore Throat (benzocaine / menthol topical)
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- Drug class: mouth and throat products
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