Vicks Dayquil Nyquil Hot Remedy Kit
FDA Label NDC 58933-556

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 Nyquil Hot Remedy (NDC 58933-556). 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, active ingredient (in each packet), 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

→ Active Ingredient (in Each Packet)

→ 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

→ Stop Use And Ask A Doctor If

→ If Pregnant Or Breast-feeding,ask A Health Professional Before Use.

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients:

→ Questions?

→ When Using This Product

→ If Pregnant Or Breast-feeding,

→ Inactive Ingredients

→ Principal Display Panel - 6 Packet Package

Other

Vicks® DayQuil™ HOT REMEDY COLD & FLU

Drug Facts

DayQuil™

MADE IN MEXICO

DIST. BY PROCTER & GAMBLE,

CINCINNATI OH 45202

Vicks® NyQuil™ HOT REMEDY COLD & FLU

Drug Facts

NyQuil™

MADE IN MEXICO

DIST. BY PROCTER & GAMBLE,
CINCINNATI OH 45202

Active Ingredient (In Each Packet)

Acetaminophen 500 mg

Dextromethorphan HBr 20 mg

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Purpose

Headache, Fever, Sore Throat, Minor Aches & Pains

Cough

Pain reliever/fever reducer

Antihistamine/Cough suppressant

Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

cough due to minor throat & bronchial irritation
sore throat
headache
minor aches & pains
fever

temporarily relieves common cold/flu symptoms:

minor aches & pains
sore throat
fever
headache
cough due to minor sore throat & bronchial irritation
cough to help you sleep
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

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.

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 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
cough that occurs with too much phlegm (mucus)
persistent or chronic cough such as occurs with smoking, asthma, or emphysema

liver disease
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 the blood thinning drug warfarin

taking sedatives or tranquilizers
taking the blood thinning drug warfarin

Stop Use And Ask A Doctor If

pain 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.

pain 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.

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


Age	Dose
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


Age	Dose
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 68 mg per dose
store at no greater than 25°C (77°F)

• each packet contains:potassium 10 mg

phenylketonurics: contains phenylalanine 68 mg per dose
store at no greater than 25°C (77°F)

Inactive Ingredients:

acesulfame potassium, aspartame, carboxymethylcellulose, citric acid, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, flavor, sodium citrate, sucrose, tricalcium phosphate

Questions?

1-800-362-1683

When Using This Product

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

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Inactive Ingredients

acesulfame potassium, aspartame, carboxymethylcellulose, citric acid, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, flavor, sodium citrate, sucrose, tricalcium phosphate

Principal Display Panel - 6 Packet Package

NEW FORMULAS

VALUE PACK

Vicks ^®DayQuil™ HOT REMEDY

COLD & FLU

Acetaminophen,Dextromethorphan HBr

Headache, Fever, Sore Throat, Minor Aches & Pains

Cough

Non-Drowsy

Vicks ^®NyQuil™ HOT REMEDY

COLD & FLU

Acetaminophen, Diphenhydramine HCl

Headache, Fever, Sore Throat, Minor Aches & Pains

Cough, Sneezing, Runny Nose

Nighttime Relief

HONEY LEMON FLAVORED

3 DAYQUIL PACKETS; 3 NYQUIL PACKETS; 6 TOTAL PACKETS

556 (556)

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