Vicks Formula 44 Cough & Sore Throat Lozenge

Vicks Formula 44 by

Drug Labeling and Warnings

Vicks Formula 44 by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

VICKS FORMULA 44 COUGH AND SORE THROAT LOZENGE- benzocaine and dextromethorphan hydrobromide lozenge 
The Procter & Gamble Manufacturing Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Vicks Formula 44 Cough & Sore Throat Lozenge

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

If pregnant or breast-feeding, ask a health professional before use.

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

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

998

VICKS FORMULA 44  COUGH AND SORE THROAT LOZENGE
benzocaine and dextromethorphan hydrobromide lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 37000-998
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE7.5 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CORN SYRUP (UNII: 9G5L16BK6N)  
SUCROSE (UNII: C151H8M554)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
ColorpurpleScoreno score
ShapeROUNDSize19mm
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 37000-998-162 in 1 CARTON11/30/202001/18/2023
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35611/30/202001/18/2023
Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 5/2023
 
The Pr

Trademark Results [Vicks Formula 44]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VICKS FORMULA 44
VICKS FORMULA 44
78228309 3024345 Dead/Cancelled
Procter & Gamble Company, The
2003-03-21

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