Vicks Dayquil And Vicks Nyquil Kit
FDA Label NDC 69423-845

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Procter & Gamble Manufacturing Company for the product Vicks Dayquil And Vicks Nyquil (NDC 69423-845). 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 ingredients (in each 30 ml), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredients (in Each 30 Ml)

→ Purpose

→ Uses

→ Warnings

→ 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

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions?

→ Principal Display Panel - Kit Carton

Other

NyQuil FOR PEOPLE WITH DIABETES COLD & FLU

Drug Facts

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.

DIST. BY: PROCTER & GAMBLE,

CINCINNATI, OH 45202

DayQuil FOR PEOPLE WITH DIABETES COLD & FLU

Drug Facts

TAMPER EVIDENT: DO NOT USE IF PRINTED SHRINKBAND SEAL AROUND THE NECK IS BROKEN OR MISSING

DIST. BY: PROCTER & GAMBLE,

CINCINNATI, OH 45202

Active Ingredients (In Each 30 Ml)

Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg

Acetaminophen 650 mg
Dextromethorphan HBr 20 mg

Purpose

Pain reliever/ fever reducer
Cough suppressant
Antihistamine

Pain reliever/Fever reducer
Cough suppressant

Uses

temporarily relieves common cold/flu symptoms:

cough due to minor throat & bronchial irritation
sore throat
headache
minor aches & pains
fever
runny nose and sneezing

temporarily relieves common cold/flu symptoms:

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

Warnings

Liver warning:This product contains acetaminophen. Severe liver damage may
occur if you take
• more than 4 doses (30 mL each) 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.

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
• more than 4 doses (30 mL each) 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.
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 .
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
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

• liver disease
• 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

taking sedatives or tranquilizers
taking the blood thinning drug warfarin

taking the blood thinning drug warfarin.

When Using This Product

excitability may occur, especially in children
marked drowsiness may occur
avoid alcoholic drinks
be careful when driving a motor vehicle or operating machinery
alcohol, sedatives, and tranquilizers may increase drowsiness

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 get worse or last 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.

Directions

take only as directed
only use the dose cup provided
do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over	30 mL every 6 hrs
children 4 to under 12 yrs	ask a doctor
children under 4 yrs	do not use

take only as directed
only use the dose cup provided
do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over	30 mL every 4 hrs
children 4 to under 12 yrs	ask a doctor
children under 4 yrs	do not use

Other Information

each 30 mL dose contains:sodium 28.23 mg
store at no greater than 25°C (77°F) and do not refrigerate

• each 30 mL contains: sodium 29 mg
• store at no greater than 25 ⁰C (77 ⁰F) and do not refrigerate

Inactive Ingredients

citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, propylene glycol, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, sucralose, water, xanthan gum

citric acid, FD&C yellow no. 6, flavor, glycerin, propylene glycol, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, sucralose, water,
xanthan gum

Questions?

1-800-362-1683

Principal Display Panel - Kit Carton

SUGAR FREE

VALUE PACK

Vicks DayQuil and NyQuil FOR PEOPLE WITH DIABETES

COLD & FLU

Vicks DayQuil FOR PEOPLE WITH DIABETES

COLD & FLU

THE DAYTIME, COUGHING, ACHING, SORE THROAT, FEVER, POWER THROUGH YOUR DAY, MEDICINE.

Acetaminophen,Dextromethorphan HBr

Headache, Fever, Sore Throat, Minor Aches & Pains

Cough

Non-Drowsy

Alcohol Free

Vicks NyQuil FOR PEOPLE WITH DIABETES

COLD & FLU

THE NIGHTTIME, SNIFFLING, SNEEZING, COUGHING, ACHING, FEVER, BEST SLEEP WITH A COLD, MEDICINE.

Acetaminophen,Doxylamine Succinate, Dextromethorphan HBr

Headache, Fever, Sore Throat, Minor Aches & Pains

Sneezing, Runny Nose

Cough

Nighttime Relief

Alcohol Free

ALSO SOLD AS DAYQUIL/NYQUIL HIGH BLOOD PRESSURE

2 BOTTLES - 1 DAYQUIL/1 NYQUIL 12 FL OZ (354 mL) EACH; TOTAL 24 FL OZ (708 mL)

845 (845)

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