VICKS FORMULA 44 NIGHTTIME COUGH AND COLD- acetaminophen, chlorpheniramine maleate, and dextromethorphan hydrobromide liquid 
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™
NIGHTTIME COUGH & COLD

Drug Facts

Active ingredients (in each 30 mL)

Acetaminophen 650 mg

Chlorpheniramine maleate 4 mg

Dextromethorphan HBr 30 mg

Purpose

Pain reliever/Fever reducer
Antihistamine
Cough suppressant

Uses

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever
  • runny nose and sneezing

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4 doses in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

Allergy Alert:

Acetaminophen may cause severe skin reactions.
Symptoms may include:

  • Skin reddening
  • Blisters
  • Rash

If a skin reaction occurs, stop use and seek medical help right away

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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.

Ask a doctor before use if you have

  • liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
  • trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product

  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if

  • pain or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back, or occurs with rash or headache that lasts.

    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.

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Directions

• take only as directed
• only use the dose cup provided
• do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over30 mL every 6 hrs
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use

Other information

  • each 30 mL dose cup contains: sodium 25 mg
  • store at no greater than 25°C and do not refrigerate

Inactive ingredients

citric acid, FD&C Red No. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Questions?

1-800-362-1683

TAMPER EVIDENT: Do not use if printed shrinkband is broken or missing.

DIST. BY PROCTER & GAMBLE,
CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 354 ml Bottle Label

VICKS ®

FORMULA 44

Nighttime COUGH & COLD

Acetaminophen

Dextromethorphan HBr,

Chlorpheniramine Maleate

Fever, Minor Aches & Pains

Cough

Sneezing, Runny Nose
12 FL OZ (354 mL)

450

VICKS  FORMULA 44 NIGHTTIME COUGH AND COLD
acetaminophen, chlorpheniramine maleate, and dextromethorphan hydrobromide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-450
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 15 mL
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
XANTHAN GUM (UNII: TTV12P4NEE)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-450-12354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/11/201703/29/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01207/11/201703/29/2023
Labeler - Procter & Gamble Manufacturing Company (004238200)

Revised: 9/2023
 
Procter & Gamble Manufacturing Company