VIcks Flu Therapy

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2023-10-16
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 21:24:10

Label at a glance#

ProductVIcks Flu Therapy Severe Cold and Flu Day
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN
Label structure11 sections

Indications and uses

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

Dosage and administration

take only as directed do not exceed 6 doses per 24 hrs Age Dose adults & children 12 yrs & over one packet every 4 hrs 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

Storage and handling

each packet contains: potassium 10 mg phenylketonurics: contains phenylalanine 64 mg per dose do not exceed 25°C.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each Packet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg
Dextromethorphan HBr 20 mg
Phenylephrine HCl 10 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/Fever reducer
Cough suppressant
Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

  • minor aches & pains
  • sore throat
  • fever
  • headache
  • cough due to minor throat & bronchial irritation
  • cough to help you sleep
  • nasal congestion
  • sinus congestion & pressure
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage

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
  • cough that occurs with too much phlegm (mucus)
  • persostent or chronic cough such as occurs with smoking, asthma, or emphysema
  • trouble urinating due to enlarged prostate gland

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.

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 6 doses per 24 hrs
AgeDose
adults & children 12 yrs & overone packet every 4 hrs
children under 12 yrsdo 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 10 mg
  • phenylketonurics: contains phenylalanine 64 mg per dose
  • do not exceed 25°C.

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, aspartame, carboxymethylcellulose, citric acid, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, flavors, sucrose, tribasic calcium phosphate

Questions?

OTC - QUESTIONS SECTION

1-800-362-1683

SPL UNCLASSIFIED SECTION

Keep outer package for complete product information.

Tamper Evident: Do not use if inner sealed packet is torn or broken.

SPL UNCLASSIFIED SECTION

MADE IN MEXICO

DIST. BY:

PROCTER & GAMBLE,

CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 9 PACKETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50% MORE

VICKS ®


DAY

FluTherapy

SEVERE COLD & FLU

Acetaminophen - Pain Reliever/Fever reducer,

Dextromethorphan HBr - Cough suppressant

Phenylephrine HCl - Nasal decongestant

  • Fast Relief of Cold & Flu symptoms
  • Soothing Vicks Vapors


HONEY LEMON FLAVOR


9 PACKETS

539539

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37000-539-012021-02-12C16284748780-1ba0f9c33-58e0-a910-e053-dadaa90a0b85Vicks ® DAY Flu Therapy Severe Cold & Flu
37000-539-012021-01-29C16284748780-1ba0f9c33-58e0-a910-e053-dadaa90a0b85Vicks ® DAY Flu Therapy Severe Cold & Flu

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-53937000-539-01, 37000-539-09

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
0b753955-b883-5e86-e063-6394a90a89c386be2aca-2347-fdcf-e053-2991aa0aa2362023-12-01WarningsExact identifier
spl set id: 86be2aca-2347-fdcf-e053-2991aa0aa236

Reported adverse events (FAERS/openFDA)#

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