Vicks DayQuil Severe Hot Remedy

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2023-02-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:38:10

Label at a glance#

ProductVicks DayQuil Severe Hot Remedy Cold and Flu plus Congestion
Active ingredientACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure10 sections

Indications and uses

• temporarily relieves common cold/flu symptoms: • nasal congestion • sinus congestion & pressure • cough due to minor throat & bronchial irritation • minor aches & pains • headache • fever • sore throat • reduces swelling of nasal passages • temporarily restores freer breathing through the nose • promotes nasal and/or sinus drainage • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial ...

Dosage and administration

• take only as directed • do not exceed 4 doses (one packet each dose) per 24 hrs Adults & children 12 yrs & over - one packet every 4 hours Children under 12 yrs - Do not use • dissolve contents of one packet into 8 oz. of hot water and stir briskly; sip while hot. Consume entire drink within 10-15 minutes • if using a microwave, add contents of one packet to 8 oz. of cool water, stir briskly before and after hea...

Storage and handling

• each packet contains: potassium 20 mg • phenylketonurics: contains phenylalanine 56 mg per dose • store at no greater than 25°C (77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each packet) Purpose

Acetaminophen 650 mg...............................Pain reliever/fever reducer
Dextromethorphan HBr 20 mg...................... Cough suppressant
Guaifenesin 400 mg...................................... Expectorant

Phenylephrine HCl 10 mg............................. Nasal decongestant

OTC - PURPOSE SECTION

Active Ingredient (in each packet) Purpose

Acetaminophen 650 mg.............................Pain reliever/fever reducer
Dextromethorphan HBr 20 mg.................... Cough suppressant
Guaifenesin 400 mg.................................... Expectorant

Phenylephrine HCl 10 mg........................... Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

• temporarily relieves common cold/flu symptoms:

• nasal congestion

• sinus congestion & pressure

• cough due to minor throat & bronchial irritation

• minor aches & pains

• headache

• fever

• sore throat

• reduces swelling of nasal passages

• temporarily restores freer breathing through the nose

• promotes nasal and/or sinus drainage

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make

coughs more productive.

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

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

  • more than 6 doses 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:

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

do not use more than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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.

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.

Overdose warning

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 as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

• take only as directed

• do not exceed 4 doses (one packet each dose) per 24 hrs

Adults & children 12 yrs & over - one packet every 4 hours

Children under 12 yrs - Do not use

• dissolve contents of one packet into 8 oz. of hot water and stir briskly; sip while hot. Consume entire drink within 10-15 minutes

• if using a microwave, add contents of one packet to 8 oz. of cool water, stir briskly before and after heating. Do not overheat

Other information

STORAGE AND HANDLING SECTION

• each packet contains: potassium 20 mg

• phenylketonurics: contains phenylalanine 56 mg per dose

• store at no greater than 25°C (77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, aspartame, citric acid, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, flavors, silicon dioxide, sucrose

Questions?

OTC - QUESTIONS SECTION

1-800-362-1683

SPL UNCLASSIFIED SECTION

MADE IN MEXICO

DIST. BY PROCTER & GAMBLE,
CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 6 packet package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAX STRENGTH

Vicks® DayQuil™ SEVERE HOT REMEDY

COLD & FLU + CONGESTION

Acetaminophen - Headache, Fever, Sore Throat, Minor Aches & Pains

Guaifenesin - Chest Congestion, Thins & Loosens Mucus

Phenylephrine HCl - Nasal Congestion, Sinus Pressure

Dextromethorphan HBr - Cough

HONEY LEMON TEAM FLAVOR

Non-Drowsy

6 POWDER PACKETS

976976

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-97669423-976-08, 69423-976-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f782ae1d-c5b4-7606-e053-6394a90a77b3e546e52c-9f4b-d66b-e053-2995a90aead32023-03-22WarningsExact identifier
spl set id: e546e52c-9f4b-d66b-e053-2995a90aead3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.