Label: CEPACOL EXTRA STRENGTH SORE THROAT CHERRY- benzocaine and menthol lozenge
- NDC Code(s): 63824-713-04, 63824-713-16, 63824-713-94
- Packager: RB Health (US) 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 May 8, 2019
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:
- pale, gray, or blue colored skin (cyanosis)
- rapid heart rate
- shortness of breath
- dizziness or lightheadedness
- fatigue or lack of energy
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
If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, 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 out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 16 Lozenge Blister Pack Carton
INGREDIENTS AND APPEARANCE
CEPACOL EXTRA STRENGTH SORE THROAT CHERRY
benzocaine and menthol lozenge
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-713 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine 15 mg Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A) Menthol, Unspecified Form 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:63824-713-16 2 in 1 CARTON 07/15/2013 1 8 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:63824-713-94 1 in 1 CARTON 07/15/2013 2 4 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:63824-713-04 1 in 1 CARTON 07/15/2013 3 4 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part356 07/15/2013 Labeler - RB Health (US) LLC (081049410)