Vicks Dayquil And Vicks Nyquil Kit
FDA Label NDC 84126-309

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 84126-309). 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 15 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 15 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

→ Stop Use And Ask A Doctor If

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Overdosage

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions?

→ When Using This Product

→ Principal Display Panel - Kit Carton

Other

VICKS ^®DayQuil™ ELDERBERRY COLD & FLU

Drug Facts

DIST. BY: PROCTER & GAMBLE,

CINCINNATI, OH 45202

VICKS® NyQuil™ ELDERBERRY COLD & FLU

Drug Facts

TAMPER EVIDENT: DO NOT USE IF PRINTED SHRINKBAND ON BOTTLE IS BROKEN OR MISSING.

DIST. BY: PROCTER & GAMBLE,

CINCINNATI, OH 45202

Active Ingredients (In Each 15 Ml)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Purpose

Pain reliever/ fever reducer
Cough suppressant

Pain reliever/Fever reducer

Cough suppressant

Antihistamine

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:

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

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may
occur if

adult takes more than 4 doses (30 mL each) in 24 hrs, which is the maximum daily amount for this product
child takes more than 4 doses (15 mL each) in 24 hrs, which is the maximum daily amount for this product
taken with other drugs containing acetaminophen
adult has 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

adult takes more than 4 doses (30 mL each) in 24 hrs, which is the maximum daily amount for this product
child takes more than 4 doses (15 mL eah) in 24 hrs, which is the maximum daily amount for this product
taken with other drugs containing acetaminophen
adult has 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)
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 5 days (children) or 7 days (adults)
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 lasts more than 5 days (children) or 7 days (adults)
• 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.

Overdosage

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
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 6 to under 12 yrs	15 mL every 4 hrs
children 4 to under 6 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 6 to under 12 yrs	15 mL every 4 hrs
children 4 to under 6 yrs	ask a doctor
children under 4 yrs	do not use

Other Information

each 15 mL contains: sodium 13 mg
store at no greater than 25°C and do not refrigerate

• each 15 mL contains: sodium 13 mg
• store at no greater than 25⁰C and do not refrigerate

Inactive Ingredients

citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor (with elderberry), glycerin, propylene glycol, saccharin sodium, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate, water, xanthan gum

Questions?

1-800-362-1683

When Using This Product

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

Principal Display Panel - Kit Carton

POWERFUL RELIEF

BLACK ELDERBERRY FLAVORED

Vicks DayQuil and NyQuil ELDERBERRY

COLD & FLU

Vicks DayQuil ELDERBERRY

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

Vicks NyQuil ELDERBERRY

COLD & FLU

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

Acetaminophen, Dextromethorphan HBr, Doxylamine succinate

Headache, Fever, Sore Throat, minor Aches & Pains

Sneezing, Runny Nose

Cough

2 BOTTLES - 12 FL OZ (354 mL) EACH; TOTAL 24 FL OZ (708 mL)

309 (309)

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