Vicks ®
05414779-f61d-8fa7-e063-6394a90aa034
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts
Purpose
Pain reliever/Fever reducer Antihistamine Cough suppressant
Medication Information
Purpose
Pain reliever/Fever reducer
Antihistamine
Cough suppressant
Description
Drug Facts
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
Section 42229-5
Drug Facts
Section 50565-1
Keep out of reach of children.
Section 53414-9
If pregnant or breast-feeding, ask a health professional before use.
Directions
• take only as directed
• only use the dose cup provided
• do not exceed 4 doses per 24 hrs
| adults & children 12 yrs & over | 30 mL every 6 hrs |
| children 4 to under 12 yrs | ask a doctor |
| children under 4 yrs | do not use |
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.
Questions?
1-800-362-1683
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
Other Information
- each 30 mL dose cup contains:sodium 25 mg
- store at no greater than 25°C and do not refrigerate
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.
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
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.
Active Ingredients (in Each 30 Ml)
Acetaminophen 650 mg
Chlorpheniramine maleate 4 mg
Dextromethorphan HBr 30 mg
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
Principal Display Panel 354 Ml Bottle Label
VICKS ®
FORMULA 44™DM
Nighttime COUGH & COLD
Acetaminophen
Dextromethorphan HBr,
Chlorpheniramine Maleate
Fever, Minor Aches & Pains
Cough
Sneezing, Runny Nose
12 FL OZ (354 mL)
Ask A Doctor Or Pharmacist Before Use If You Are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
Structured Label Content
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
Section 42229-5 (42229-5)
Drug Facts
Section 50565-1 (50565-1)
Keep out of reach of children.
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use.
Purpose
Pain reliever/Fever reducer
Antihistamine
Cough suppressant
Directions
• take only as directed
• only use the dose cup provided
• do not exceed 4 doses per 24 hrs
| adults & children 12 yrs & over | 30 mL every 6 hrs |
| children 4 to under 12 yrs | ask a doctor |
| children under 4 yrs | do not use |
Do Not Use (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.
Questions?
1-800-362-1683
Liver Warning (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
Other Information (Other information)
- each 30 mL dose cup contains:sodium 25 mg
- store at no greater than 25°C and do not refrigerate
Sore Throat Warning (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.
Inactive Ingredients (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
When Using This Product (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 (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.
Active Ingredients (in Each 30 Ml) (Active ingredients (in each 30 mL))
Acetaminophen 650 mg
Chlorpheniramine maleate 4 mg
Dextromethorphan HBr 30 mg
Ask A Doctor Before Use If You Have (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
Principal Display Panel 354 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 354 ml Bottle Label)
VICKS ®
FORMULA 44™DM
Nighttime COUGH & COLD
Acetaminophen
Dextromethorphan HBr,
Chlorpheniramine Maleate
Fever, Minor Aches & Pains
Cough
Sneezing, Runny Nose
12 FL OZ (354 mL)
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
Advanced Ingredient Data
Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:07:11.788547 · Updated: 2026-03-14T23:10:24.980101