Indications and uses
temporarily relieves common cold/flu symptoms: nasal congestion cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever
Vicks
- Manufacturer
- Procter & Gamble Manufacturing Company
- Effective date
- 2022-12-08
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:45:05
Label at a glance#
ProductVicks Cough and Cold Severe
Active ingredientACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure11 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 4 hrs children 6 to under 12 yrs 15 mL every 4 hrs children 4 to under 6 yrs ask a doctor children under 4 yrs do not use
Storage and handling
each 15 mL contains: sodium 44 mg Store at no greater than 25C. Do not refrigerate.
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredients (in each 15 mL)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Purpose
Pain reliever/Fever reducer
Cough suppressant
Nasal decongestant
Uses
temporarily relieves common cold/flu symptoms:
- nasal congestion
- cough due to minor throat & bronchial irritation
- sore throat
- headache
- minor aches & pains
- fever
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 4 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product
- child takes more than 4 doses (15 mL each) in 24 hours, which is the maximum daily amount for this product
- taken with other drugs containing acetaminophen
- adult has 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
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- peristent or chronic cough such as occurs with smoking, asthma, or emphysema
- a sodium-restricted diet
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin
OTC - WHEN USING SECTION
When using this product, do not use more than directed
Stop use and ask a doctor if
- you get nervous, dizzy or sleepless
- pain, nasal congestion or cough gets worse or lasts more than 5 days (children) 7 days (adults)
- 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 4 hrs
children 6 to under 12 yrs 15 mL every 4 hrs
children 4 to under 6 yrs ask a doctor
children under 4 yrs do not use
Other information
- each 15 mL contains: sodium 44 mg
- Store at no greater than 25C. Do not refrigerate.
Inactive ingredients
anhydrous citric acid, beta carotene, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose, xanthan gum
Questions?
1-800-362-1683
SPL UNCLASSIFIED SECTION
DIST. BY: PROCTER & GAMBLE, CINCINNATI, OH 45202
Made in Canada
PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label
VICKS®
MAX Strength
Cough & Cold SEVERE
Acetaminophen - pain reliever/fever reducer
Dextromethorphan HBr - cough suppressant
Phenylephrine HCl - nasal decongestant
FREE OF:
- Artificial Dyes & Flavors,
- Alcohol
- High Fructose Corn Syrup
Non-Drowsy
8 FL OZ (236 ml)
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 37000-768-06 | 2021-02-12 | C162847 | 48780-1 | ba0f9c33-1c6a-a910-e053-dadaa90a0b85 | VICKS ® Cough & Cold Severe |
| 37000-768-06 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1c6a-a910-e053-dadaa90a0b85 | VICKS ® Cough & Cold Severe |
Products#
Every source-derived product name is available through these pages.
- Vicks Cough and Cold Severe
- Acetaminophen, Chlorpheniramine maleate, and Dextromethorphan Hydrobromide
- SODIUM CITRATE
- ACETAMINOPHEN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- XANTHAN GUM
- SUCRALOSE
- SORBITOL
- SODIUM CHLORIDE
- ANHYDROUS CITRIC ACID
- BETA CAROTENE
- GLYCERIN
- PROPYLENE GLYCOL
- WATER
- SACCHARIN SODIUM
- SODIUM BENZOATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 37000-768 | 37000-768-06 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| XANTHAN GUM | TTV12P4NEE | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| SORBITOL | 506T60A25R | IACT |
| SODIUM CHLORIDE | 451W47IQ8X | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| BETA CAROTENE | 01YAE03M7J | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SODIUM BENZOATE | OJ245FE5EU | 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 |
|---|---|---|---|---|---|---|
| f408ac83-3458-5834-e053-2a95a90aacbe | 87360e69-025b-df27-e053-2a91aa0a2a26 | 2023-02-06 | Warnings | 87360e69-025b-df27-e053-2a91aa0a2a26 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.