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Drug Facts
DIST. BY PROCTER & GAMBLE,
CINCINNATI OH 45202
Vicks Vapocool Lozenge
FDA Label NDC 84126-366
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Procter & Gamble Manufacturing Company for the product Vicks Vapocool (NDC 84126-366). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredients (per drop), purpose, uses, methemoglobinemia warning–, allergy alert:, sore throat warning –, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients (Per Drop)
Benzocaine 15 mg
Menthol 20 mg
Purpose
Oral anesthetic
Oral anesthetic
Uses
temporarily relieves occasional minor irritation and pain due to
- sore throat
- sore mouth
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. If a skin reaction occurs, stop use and seek medical help right away.
Sore Throat Warning –
Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 12 years of age.
Do Not Use
- for teething
- in children under 2
When Using This Product
do not exceed recommended dosage
Ask A Doctor Before Use If You Have
- a severe sore throat accompanied by difficulty in breathing or that lasts more than 2 days
- a sore throat accompanied by fever, headache, rash, swelling, nausea or vomiting
Stop Use And Ask A Doctor If
- sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- adults and children 12 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor.
- children under 12 years: do not use.
Other Information
- Store at no greater than 25°C (77°F)
- contains soy
Inactive Ingredients
acacia, ascorbyl palmiltate, beta-carotene, corn syrup, FD&C Blue No. 1, flavor, maltodextrin, propylene glycol, sucrose, sunflower oil, vitamin E DL-alpha, water
Questions?
1-800-707-1709
Principal Display Panel - 30 Medicated Drops
VICKS ®
VapoCOOL
SEVERE
MENTHOL & BENZOCAINE - ORAL ANESTHETICS
+INTENSE PAIN RELIEF
SOOTHES & NUMBS
SORE THROATS
ICY MINT
30 MEDICATED DROPS
366 (366)
* Please review the disclaimer below.
