FDA Label for Vicks Vapocool Sore Throat
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENTS (IN EACH 15 ML)
- PURPOSE
- USES
- METHEMOGLOBINEMIA WARNING –
- ALLERGY ALERT:
- SORE THROAT WARNING –
- DO NOT USE
- WHEN USING THIS PRODUCT
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSE WARNING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - 177 ML BOTTLE LABEL
Vicks Vapocool Sore Throat Product Label
The following document was submitted to the FDA by the labeler of this product The Procter & Gamble Manufacturing Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
MADE IN CANADA
DIST. BY: PROCTER & GAMBLE,
CINCINNATI, OH 45202
Active Ingredients (In Each 15 Ml)
Benzocaine (5 %)
Menthol (1 %)
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.
Overdose Warning
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- adults and children 12 years and over: Apply to the affected area (one spray). Gargle, swish around in the mouth, or allow to remain in place at least 1 minute and then spit out. Use up to 4 times daily or as directed by a doctor.
- children under 12 years, do not use.
Other Information
- do not exceed 25°C. Do not refrigerate.
Inactive Ingredients
alcohol, FD&C Blue No. 1, FD&C Red No. 40, flavors, glycerin, propylene glycol, purified water, saccharin sodium, sucralose
Questions?
1-800-283-4879
Principal Display Panel - 177 Ml Bottle Label
VICKS®
VapoCOOL
SORE THROAT
BENZOCAINE & MENTHOL - ORAL ANESTHETICS
Cooling Numbing
Soothes Throat Pain
Fast-acting
CHERRY BERRY FREEZE
6 FL OZ (177 ml)
* Please review the disclaimer below.