Indications and uses
temporarily relieves: sore throat sore mouth minor mouth irritation pain associated with canker sores cough due to minor throat and bronchial irritation as may occur with the common cold
Vicks Formula 44
- Manufacturer
- The Procter & Gamble Manufacturing Company
- Effective date
- 2022-12-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:44:56
Label at a glance#
ProductVicks Formula 44 Cough and Sore Throat Lozenge
Active ingredientBENZOCAINE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure10 sections
Dosage and administration
adults and children 12 years and older: take 2 lozenges (one immediately after the other) and allow each lozenge to dissolve slowly in the mouth; may be repeated every 4 hours as needed, not to exceed 12 lozenges in 24 hours, or as directed by doctor or dentist children 6 to under 12 years of age: take 1 lozenge and allow product to dissolve slowly in the mouth; may be repeated every 4 hours as need, not to exceed...
Storage and handling
Store at 20°-25°C (68°-77°F) in a dry place contains soy
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredients (per drop)
Benzocaine 7.5 mg
Dextromethorphan hydrobromide 5 mg
Purpose
Oral anesthetic
Cough suppressant
Uses
temporarily relieves:
- sore throat
- sore mouth
- minor mouth irritation
- pain associated with canker sores
- cough due to minor throat and bronchial irritation as may occur with the common cold
Warnings
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 6 years of age.
Do not use
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- for teething
- in children under 2
When using this product
do not exceed recommended dosage
Ask a doctor before use if you have
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- cough that occurs with too much phlegm (mucus)
- 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 • irritation, pain, or redness persists or worsens
- swelling develops
- cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.
These could be signs of a serious condition
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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 older: take 2 lozenges (one immediately after the other) and allow each lozenge to dissolve slowly in the mouth; may be repeated every 4 hours as needed, not to exceed 12 lozenges in 24 hours, or as directed by doctor or dentist
children 6 to under 12 years of age: take 1 lozenge and allow product to dissolve slowly in the mouth; may be repeated every 4 hours as need, not to exceed 6 lozenges in 24 hours, or as directed by a doctor or dentist
children under 6 years of ag: do not use.
Other information
- Store at 20°-25°C (68°-77°F) in a dry place
- contains soy
Inactive ingredients
acesulfame potassium, corn syrup, FD&C Blue No. 1, FD&C Red No. 40, flavors, propylene glycol, sucrose, water
Questions?
1-800-342-6844
SPL UNCLASSIFIED SECTION
DIST. BY PROCTER & GAMBLE,
CINCINNATI OH 45202
PRINCIPAL DISPLAY PANEL - 16 lozenge blister in carton
VICKS®
FORMULA 44
COUGH & SORE THROAT LOZENGE
Benzocaine Oral Anesthetic /
Dextromethorphan HBr Cough Suppressant
Soothes Sore Throat Pain & Irritation
Relieves Cough
16 LOZENGES
actual size
Products#
Every source-derived product name is available through these pages.
- Vicks Formula 44 Cough and Sore Throat Lozenge
- Benzocaine and Dextromethorphan hydrobromide
- WATER
- FD&C BLUE NO. 1
- CORN SYRUP
- SUCROSE
- PROPYLENE GLYCOL
- BENZOCAINE
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- ACESULFAME POTASSIUM
- FD&C RED NO. 40
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 37000-998 | 37000-998-16 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| CORN SYRUP | 9G5L16BK6N | IACT |
| SUCROSE | C151H8M554 | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| BENZOCAINE | U3RSY48JW5 | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| ACESULFAME POTASSIUM | 23OV73Q5G9 | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| fbe4b19b-7b0a-a9a7-e053-6294a90a2e94 | bb9edf22-f30f-6a1b-e053-2a95a90a7800 | 2023-05-17 | Warnings | bb9edf22-f30f-6a1b-e053-2a95a90a7800 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.