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Drug Facts
DIST. BY
PROCTER & GAMBLE,
CINCINNATI, OH 45202
Vicks Formula 44 Lozenge
FDA Label NDC 37000-997
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 Formula 44 (NDC 37000-997). 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 ingredient (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 Ingredient (Per Drop)
Menthol 5.8 mg
Purpose
Cough suppressant/Oral anesthetic
Uses
temporarily relieves:
- cough associated with a cold
- occasional minor irritation or sore throat
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 unless directed by doctor.
Ask A Doctor Before Use If You Have
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- cough accompanied by excessive phlegm (mucus)
- a severe sore throat accompanied by difficulty in breathing or that lasts more than 2 days
Stop Use And Ask A Doctor If
- cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache.
- sore mouth symptoms do not improve in 7 days
- 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. 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 12 years and under: do not use
Other Information
- Store at 20°-25°C (68°-77°F) in a dry place
- Contains soy
Inactive Ingredients
corn syrup, eucalyptus oil, FD&C Red No. 40, flavors, sucrose, water
Questions?
1-800-342-6844
Principal Display Panel - 20 Drop Bag
VICKS®
FORMULA 44™
COUGH DROPS
MENTHOL • Cough Suppressant / Oral Anesthetic
Cooling Menthol
Soothes Sore Throat
Relieves Cough
actual size
50 MEDICATED DROPS
997 (997)
* Please review the disclaimer below.
