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Drug Facts
DIST. BY:
PROCTER & GAMBLE
CINCINNATI, OH 45202
Vicks Vapocool Lozenge
FDA Label NDC 69423-796
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 69423-796). 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, sore throat warning –, ask a doctor before use if you have, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients (Per Drop)
Menthol 20 mg
Purpose
Oral anesthetic
Uses
temporarily relieves occasional minor irritation and pain due to
- sore throat
- sore mouth
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.
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: 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 20°-25°C (68°-77°F) in a dry place
- contains soy
Inactive Ingredients
corn syrup, FD&C Blue No. 1, FD&C Red No. 40, flavors, sucrose, water
Questions?
1-800-707-1709
Principal Display Panel - 18 Drops In A Bag
VICKS®
VapoCOOL
SEVERE
MENTHOL • ORAL ANESTHETIC
MAX STRENGTH • FAST RELIEF
SOOTHES SORE THROAT
CHERRY FREEZE
18 MEDICATED DROPS
69423-957 (957)
* Please review the disclaimer below.
