Label: CEPACOL EXTRA STRENGTH SORE THROAT AND COUGH- benzocaine and dextromethorphan hydrobromide lozenge
- NDC Code(s): 63824-744-16, 63824-744-36, 63824-744-94
- Packager: RB Health (US) LLC
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated September 27, 2023
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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Warnings
Methemoglobinemia warning
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)
- headache
- rapid heart rate
- shortness of breath
- dizziness or lightheadedness
- fatigue or lack of energy
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
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.
Do not use
- 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 do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- for teething
- in children under 6 years of age
Ask a doctor before use if you have
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- cough that occurs with too much phlegm (mucus)
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 develops
- cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.
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Directions
adults and children 12 years of age and older take 2 lozenges (one immediately after the other) and allow each lozenge to dissolve slowly in the mouth; may be repeated every 4 hours as needed, not to exceed 12 lozenges in 24 hours, or as directed by a doctor or dentist children 6 to under 12 years of age take 1 lozenge and allow product to dissolve slowly in the mouth; may be repeated every 4 hours as needed, not to exceed 6 lozenges in 24 hours, or as directed by a doctor or dentist children under 6 years of age do not use - Other information
- Inactive ingredients
- Questions?
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PRINCIPAL DISPLAY PANEL - 16 Lozenge Blister Pack Carton
NDC 63824-744-16
READ ALL WARNINGSCēpacol ®
EXTRA STRENGTH#1
DOCTOR
RECOMMENDED †SORE THROAT & COUGH
Benzocaine 7.5 mg Oral Pain Reliever | Dextromethorphan HBr 5 mg Cough Suppressant- Relieves Sore Throat Pain
- Quiets Cough • Fast Acting
- Maximum Numbing*
16 Lozenges mixed berry
*based on amount of benzocaine per adult dose
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INGREDIENTS AND APPEARANCE
CEPACOL EXTRA STRENGTH SORE THROAT AND COUGH
benzocaine and dextromethorphan hydrobromide lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-744 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 7.5 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 5 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 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 BERRY Imprint Code S Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63824-744-16 2 in 1 CARTON 05/05/2014 1 8 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:63824-744-94 1 in 1 CARTON 05/05/2014 04/14/2024 2 4 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:63824-744-36 3 in 1 CARTON 05/01/2019 04/14/2024 3 12 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 05/05/2014 Labeler - RB Health (US) LLC (081049410)