Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5), Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)
Reckitt Benckiser LLC
ORAL
OTC DRUG
temporary relief of occasional - sore throat - sore mouth - minor mouth irritation - pain associated with canker sores
OTC monograph not final
CEPACOL SORE THROAT- BENZOCAINE AND MENTHOL LOZENGE RECKITT BENCKISER LLC _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._ ---------- CĒPACOL SORE THROAT _DRUG FACTS_ _ACTIVE INGREDIENTS (IN EACH LOZENGE)_ _PURPOSES_ Benzocaine 15 mg Oral pain reliever Menthol 3.6 mg Oral pain reliever US ES temporary relief of occasional sore throat sore mouth minor mouth irritation pain associated with canker sores WARNINGS 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. 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. DIRECTIONS 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 OTHER INFORMATION 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 INACTIVE INGREDIENTS D&C Red #33, FD&C Red #40, flavors, isomalt, maltitol, propylene glycol, purified water, sodium bicarbonate, sucralose QUES TIONS ? CALL 1-888-963-3382 You may also report side effects to Lees het volledige document