Label: CEPACOL SORE THROAT- benzocaine and menthol lozenge
- NDC Code(s): 63824-712-16, 63824-712-94, 63824-712-98
- Packager: Reckitt Benckiser LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated March 22, 2013
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Active ingredients (in each lozenge) Purposes 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.
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
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.
- 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, sucraloseClose
You may also report side effects to this phone number.Close
- SPL UNCLASSIFIED SECTION
Made in EnglandClose
- PRINCIPAL DISPLAY PANEL - 16 Lozenge Carton
Benzocaine 15 mg | Menthol 3.6 mg
Oral Pain Reliever
- Instant Acting
- Maximum Strength Numbing
- INGREDIENTS AND APPEARANCE
CEPACOL SORE THROAT
benzocaine and menthol lozenge
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-712 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine 15 mg Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol 3.6 mg Inactive Ingredients Ingredient Name Strength D&C red no. 33 (UNII: 9DBA0SBB0L) FD&C red no. 40 (UNII: WZB9127XOA) isomalt (UNII: S870P55O2W) maltitol (UNII: D65DG142WK) propylene glycol (UNII: 6DC9Q167V3) water (UNII: 059QF0KO0R) sodium bicarbonate (UNII: 8MDF5V39QO) sucralose (UNII: 96K6UQ3ZD4) Product Characteristics Color RED Score no score Shape ROUND Size 18mm Flavor CHERRY Imprint Code S Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63824-712-16 2 in 1 CARTON 1 8 in 1 BLISTER PACK 2 NDC:63824-712-98 72 in 1 CARTON 2 8 in 1 BLISTER PACK 3 NDC:63824-712-94 1 in 1 CARTON 3 4 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part356 03/15/2013 Labeler - Reckitt Benckiser LLC (094405024)