Vicks NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM

Manufacturer
The Procter & Gamble Manufacturing Company | Wanbury | Kongo Chemical Co., Ltd.
Effective date
2023-10-18
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
legacy-cache
Hydrated at
2026-08-01 21:23:59

Label at a glance#

ProductVicks NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN
Label structure19 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 runny nose sneezing

Dosage and administration

• take only as directed • do not exceed 6 doses per 24 hrs • 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 Age Dose adults & children 12 yrs & over one packet (dose) every 4 hours children under 12 yrs ...

Storage and handling

• each packet contains: potassium 10 mg • phenylketonurics: contains phenylalanine 68 mg per dose • do not exceed 25°C.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient (in each Packet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen650 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 10 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Antihistamine, 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
  • runny nose
  • sneezing

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.
  • with any other product containing diphenhydramine, even one used on the skin.
  • 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
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or 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
  • taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • Do not use more than directed
  • excitability may occur especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery

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.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

• 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

AgeDose
adults & children 12 yrs & overone packet (dose) every 4 hours
children under 12 yrsdo not use

Other information

STORAGE AND HANDLING SECTION

• each packet contains:potassium 10 mg

• phenylketonurics: contains phenylalanine 68 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

Tamper Evident: Do not use if sachet is opened or torn

Keep outer package for complete product information.

SPL UNCLASSIFIED SECTION

MADE IN MEXICO

DIST. BY PROCTER & GAMBLE,

CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 8 packet package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAX STRENGTH

Vicks® NyQuil™ HOT REMEDY

RAPID RELIEF MULTI-SYMPTOM

COLD & FLU + CONGESTION

Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl

Headache, Fever, Sore Throat, Minor Aches & Pains

Sneezing, Runny Nose, Cough

Nasal Congestion, Sinus Pressure

Nighttime Relief

HONEY LEMON FLAVORED

8 POWDER PACKETS

776776

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-77669423-776-01, 69423-776-08

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#

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0b76e785-a4a6-ee99-e063-6394a90aeb5af775cd99-9ddf-cee3-e053-6294a90a47cb2023-12-01WarningsExact identifier
spl set id: f775cd99-9ddf-cee3-e053-6294a90a47cb

Reported adverse events (FAERS/openFDA)#

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