说明与适用边界
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spl product data elements
Cepacol Extra Strength Sore Throat honey lemon Benzocaine and Menthol D&C YELLOW NO. 10 FD&C YELLOW NO. 6 ISOMALT MALTITOL PROPYLENE GLYCOL WATER SODIUM BICARBONATE SUCRALOSE BENZOCAINE BENZOCAINE MENTHOL MENTHOL S Honey-Lemon
spl unclassified section
Drug Facts
Dist. by: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in England
活性成分 / Active ingredient
Active ingredients (in each lozenge) Purposes Benzocaine 15 mg Oral pain reliever Menthol 2.6 mg Oral pain reliever
active ingredient table
<table width="80%"><col align="left" valign="top" width="70%"/><col align="right" valign="top" width="30%"/><thead><tr><th><content styleCode="italics">Active ingredients (in each lozenge)</content></th><th><content styleCode="italics">Purposes</content></th></tr></thead><tbody><tr><td>Benzocaine 15 mg</td><td>Oral pain reliever</td></tr><tr><td>Menthol 2.6 mg</td><td>Oral pain reliever</td></tr></tbody></table>
用途 / Purpose
Active ingredients (in each lozenge) Purposes Benzocaine 15 mg Oral pain reliever Menthol 2.6 mg Oral pain reliever
purpose table
<table width="80%"><col align="left" valign="top" width="70%"/><col align="right" valign="top" width="30%"/><thead><tr><th><content styleCode="italics">Active ingredients (in each lozenge)</content></th><th><content styleCode="italics">Purposes</content></th></tr></thead><tbody><tr><td>Benzocaine 15 mg</td><td>Oral pain reliever</td></tr><tr><td>Menthol 2.6 mg</td><td>Oral pain reliever</td></tr></tbody></table>
适应证 / Indications and usage
Uses Temporary relief of occasional sore throat sore mouth minor mouth irritation pain associated with canker sores
警告 / Warnings
Warnings METHEMOGLOBINEMIA WARNING Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. 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 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 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.
禁用事项 / Do not use
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.
停用事项 / Stop use
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
孕哺期 / Pregnancy or breastfeeding
If pregnant or breast-feeding, ask a health professional before use.
儿童安全 / Keep out of reach of children
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.
用法用量原文 / Dosage and administration
Directions adults and children 5 years of age and older: allow one 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
储存 / Storage and handling
Other information store between 20-25°C (68-77°F) protect contents from humidity
辅料 / Inactive ingredients
Inactive ingredients D&C yellow no. 10, FD&C yellow no. 6, flavors, isomalt, maltitol, propylene glycol, purified water, sodium bicarbonate, sucralose
questions
Questions? Call 1-866-682-4639 You may also report side effects to this phone number.
package label principal display panel
CEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE 1
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 7 / 20250624
- 获取时间
- 2026-10-08
- 许可
- openFDA public data; retain original label attribution. See 查看来源 and dataset source notices. Public access does not imply approval or unrestricted rights to every submitted label.

