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Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTION drug information

ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE
The Procter & Gamble Manufacturing Company · ORAL

Product NDC: 69423-986

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Generic nameACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE
Labeler / manufacturerThe Procter & Gamble Manufacturing Company
RouteORAL
Drug classDrug class not supplied in source label
Product NDC69423-986
Label effective date2026-09-08

Official product label reference

Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTION — The Procter & Gamble Manufacturing Company

This page contains 16 source sections for ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE, oral route. Label set efb5f0b9-9825-ab23-e053-2995a90a26ab, version 9.

Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label

Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.

Uses described in the label

Uses temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation cough to help you sleep minor aches & pains headache fever sore throat runny nose & sneezing reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage

Purpose

Purpose Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant
Dosage and administration — label text
Directions take only as directed do not exceed 8 caplets per 24 hrs adults & children 12 yrs & over 2 caplets with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use Table text from source: | adults & children 12 yrs & over | 2 caplets with water every 4 hrs | children 4 to under 12 yrs | ask a doctor | children under 4 yrs | do not use
Warnings
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 caplets in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day 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 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 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 do not use more than directed 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 you get nervous, dizzy or sleepless pain, nasal congestion, 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 as well as for children even if you do not notice any signs or symptoms.
Unclassified section
Drug Facts TAMPER EVIDENT: This package is safety-sealed & child resistant. Use only if blisters are intact. If difficult to open, use scissors. DIST. BY PROCTER & GAMBLE, CINCINNATI OH 45202
Active ingredient
Active ingredients (in each caplet) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg Purpose Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant
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.
Ask a doctor before use
Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes 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
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin
While using this medicine
When using this product do not use more than directed 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
When to stop use and seek help
Stop use and ask a doctor if you get nervous, dizzy or sleepless pain, nasal congestion, 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.
Pregnancy or breast feeding
If pregnant or breast-feeding, ask a health professional before use.
Child safety
Keep out of reach of children.
Storage and handling
Other information store at no greater than 25ºC
Inactive ingredient
Inactive ingredients crospovidone, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide
Questions
Questions? 1-800-362-1683

Official sources and product identifiers

Substances listed: ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE

RxNorm identifiers: 1546881

Package NDC codes

69423-986-24

Further research and background

These are external searches for related information. Research, encyclopedia and news articles have not been imported into this product record.

Coverage and corrections

The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.

Source retrieved 2026-10-02. Read the source policy.