Vicks Dayquil Hot Remedy Rapid Relief Multi-symptom Powder, For Solution
FDA Label NDC 58933-550

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Procter & Gamble Manufactura S De Rl De Cv for the product Vicks Dayquil Hot Remedy Rapid Relief Multi-symptom (NDC 58933-550). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, uses, liver warning, allergy alert:, sore throat warning, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Otc - Active Ingredient

→ Otc - Purpose

→ Uses

→ Liver Warning

→ Allergy Alert:

→ Sore Throat Warning

→ Do Not Use

→ Ask A Doctor Before Use If You Have

→ Ask A Doctor Or Pharmacist Before Use If You Are

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Overdose Warning

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions?

→ Allergy Alert

→ Sore Throat Warming

→ Principal Display Panel - 16 Packet Package

Other

Vicks® DayQuil™ HOT REMEDY RAPID RELIEF MULTI-SYMPTOM COLD & FLU + CONGESTION

Drug Facts

MADE IN MEXICO

DIST. BY PROCTER & GAMBLE,

CINCINNATI OH 45202

Vicks® NyQuil™ HOT REMEDY RAPID RELIEF MULTI-SYMPTOM COLD & FLU + CONGESTION

Drug Facts

MADE IN MEXICO

DIST. BY PROCTER & GAMBLE,

CINCINNATI OH 45202

Otc - Active Ingredient

Active Ingredient (in each packet) Purpose

Acetaminophen 500 mg
Dextromethorphan HBr 20 mg

Phenylephrine HCl 10 mg

Active Ingredient (in each packet) Purpose

Acetaminophen 650 mg
Diphenhydramine HCl 25 mg

Phenylephrine HCl 10 mg

Otc - Purpose

Active Ingredient (in each packet) Purpose

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

Active Ingredient (in each packet) Purpose

Pain reliever/fever reducer
Antihistamine/Cough suppressant
Nasal decongestant

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

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

Liver Warning

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

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:

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.
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.

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

liver disease
heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
cough that occurs with too much phlegm (mucus)
persistent or chronic cough such as occurs with smoking, asthma, or emphysema
trouble urinating due to enlarged prostate gland

liver disease
heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
cough that occurs with too much phlegm (mucus)
persistent 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

taking the blood thinning drug warfarin

taking the blood thinning drug warfarin
taking sedatives or tranquilzers

When Using This Product

do not use more than directed

• 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

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.

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

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdose Warning

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

• 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

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

Children under 12 yrs - Do not use

• 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

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

Children under 12 yrs - Do not use

Other Information

• each packet contains: potassium 10 mg

• phenylketonurics: contains phenylalanine 64 mg per dose

• do not exceed 25°C.

• each packet contains: potassium 10 mg

• phenylketonurics: contains phenylalanine 68 mg per dose

• do not exceed 25°C

Inactive Ingredients

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?

1-800-362-1683

Allergy Alert

Acetaminophen may cause severe skin reactions. Symptoms may include:

Skin reddening
Blisters
Rash

Sore Throat Warming

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.

Principal Display Panel - 16 Packet Package

MAX STRENGTH

Vicks® DayQuil™ HOT REMEDY

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

Dextromethorphan HBr - Cough

Phenylephrine HCl - Nasal Congestion, Sinus Pressure

Vicks® NyQuil™ HOT REMEDY

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

Diphenhydramine HCl - Sneezing, Runny Nose, Cough

Phenylephrine HCl - Nasal Congestion, Sinus Pressure

RAPID RELIEF

MULTI-SYMPTOM

COLD & FLU + CONGESTION

Nighttime Relief

HONEY LEMON TEA FLAVORED

10 DAYQUIL POWDER PACKETS; 6 NYQUIL POWDER PACKETS; 16 TOTAL POWDER PACKETS

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