Indications and 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
VICKS
- Manufacturer
- Procter & Gamble Manufacturing Company
- Effective date
- 2026-09-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- daily-update
- Hydrated at
- 2026-09-22 03:02:35
Label at a glance#
ProductVICKS FORMULA 44DM NIGHTTIME COUGH and COLD
Active ingredientACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure19 sections
Dosage and administration
• 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
Storage and handling
each 30 mL dose cup contains: sodium 25 mg store at no greater than 25°C and do not refrigerate
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
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.
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.
SPL UNCLASSIFIED SECTION
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 & over | 30 mL every 6 hrs |
| children 4 to under 12 yrs | ask a doctor |
| children under 4 yrs | do 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
SPL UNCLASSIFIED SECTION
TAMPER EVIDENT: Do not use if printed shrinkband is broken or missing.
SPL UNCLASSIFIED SECTION
DIST. BY PROCTER & GAMBLE,
CINCINNATI OH 45202
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)
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0323900039193 | GTIN-13: 0323900039193 EAN-13: 0323900039193 GTIN-12: 323900039193 UPC-A: 323900039193 GTIN storage (14 digits): 00323900039193 | 450.jpg |
| Data code | Data Matrix | 91050838 | 450.jpg | |
| Data code | Data Matrix | 91073246 | 450.jpg |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69423-811-12 | 2024-01-30 | C162847 | 48780-1 | 1030e365-3d35-111a-e063-dadaa90a10e2 | VICKS ® FORMULA 44™DM NIGHTTIME COUGH & COLD |
| 69423-811-12 | 2024-01-30 | C162847 | 48780-1 | 1030e365-3d35-111a-e063-dadaa90a10e2 | VICKS ® FORMULA 44™DM NIGHTTIME COUGH & COLD |
Products#
Every source-derived product name is available through these pages.
- VICKS FORMULA 44DM NIGHTTIME COUGH and COLD
- Acetaminophen, Dextromethorphan HBr, Chlorpheniramine Maleate
- ACETAMINOPHEN
- CHLORPHENIRAMINE MALEATE
- CHLORPHENIRAMINE
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- XANTHAN GUM
- SUCRALOSE
- CITRIC ACID MONOHYDRATE
- FD&C RED NO. 40
- GLYCERIN
- SORBITOL
- PROPYLENE GLYCOL
- WATER
- SACCHARIN SODIUM
- SODIUM BENZOATE
- SODIUM CITRATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69423-811 | 69423-811-12 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| CHLORPHENIRAMINE MALEATE | V1Q0O9OJ9Z | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| XANTHAN GUM | TTV12P4NEE | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| SORBITOL | 506T60A25R | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 5 | 2025-10-03 | full-release | 2026-06-01 01:15:42 |
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 |
|---|---|---|---|---|---|---|
| 4040f61e-bc9e-6060-e063-6294a90a7b96 | 05414779-f61d-8fa7-e063-6394a90aa034 | 2025-10-03 | Warnings | 05414779-f61d-8fa7-e063-6394a90aa034 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.