FDA Label for Vicks Dayquil And Vicks Nyquil Severe Cold And Flu

View Indications, Usage & Precautions

Vicks Dayquil And Vicks Nyquil Severe Cold And Flu Product Label

The following document was submitted to the FDA by the labeler of this product The Procter & Gamble Manufacturing Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other

DayQuil Severe Cold & Flu

Drug Facts

NyQuil Severe Cold & Flu

Drug Facts

Dist. by Proctor & Gamble, Cincinnati OH 45202

Otc - Purpose

Active ingredients (in each 15 mL tablespoon)	Purpose
Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan HBr 10 mg	Cough suppressant
Guaifenesin 200 mg	Expectorant
Phenylephrine HCl 5 mg	Nasal decongestant

Active ingredients (in each 30 mL dose cup)	Purpose
Acetaminophen 650 mg	Pain reliever/fever reducer
Dextromethorphan HBr 20 mg	Cough suppressant
Doxylamine succinate 12.5 mg	Antihistamine
Phenylephrine HCl 10 mg	Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:
- nasal congestion
- sinus congestion & pressure
- cough due to minor throat & bronchial irritation
- minor aches & pains
- headache
- fever
- sore throat
- reduces swelling of nasal passages
- temporarily restores freer breathing through the nose
- promotes nasal and/or sinus drainage
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Liver Warning

This product contains acetaminophen. Severe liver damage may occur if

adult takes more than 4 doses (30 mL each) in 24 hrs
child takes more than 4 doses (15 mL each) in 24 hrs
taken with other drugs containing acetaminophen
adult has 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 4 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

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.
to make a child sleep

Ask A Doctor Before Use If You Have

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

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, chronic bronchitis, or emphysema
trouble urinating due to enlarged prostate gland
a sodium-restricted diet

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Otc - When Using

When using this product, do not use more than directed.

Stop Use And Ask A Doctor If

you get nervous, dizzy or sleepless
pain, nasal congestion, 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.

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

Taking more than directed can cause serious health problems. 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 - see Overdose warning
use dose cup or tablespoon (TBSP)
do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over	30 mL (2 TBSP) every 4 hrs
children 6 to under 12 yrs	15 mL (1 TBSP) every 4 hrs
children 4 to under 6 yrs	ask a doctor
children under 4 yrs	do not use

when using other DayQuil or NyQuil ^® products, carefully read each label to ensure correct dosing

take only as directed - see Overdose warning
use dose cup or tablespoon (TBSP)
do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over	30 mL (2 TBSP) every 4 hrs
children 4 to under 12 yrs	ask a doctor
children under 4 yrs	do not use

when using other DayQuil ^® or NyQuil products, carefully read each label to ensure correct dosing

Other Information

each 15 mL tablespoon contains: sodium 47 mg
store at room temperature

each 30 mL dose cup contains: sodium 92 mg
store at room temperature

Inactive Ingredients

citric acid, FD&C Yellow No. 6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum

citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum

Questions?

1-800-251-3374

1-800-362-1683

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers
taking the blood thinning drug warfarin

When Using This Product

do not use more than directed
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

Principal Display Panel - Kit Carton

NEW
Fights More
Symptoms
than DayQuil/NyQuil
Cold & Flu

VICKS ^®

DayQuil^®
SEVERE

COLD & FLU

Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr,
Guaifenesin

MAX
STRENGTH

Non-Drowsy
Alcohol Free

Headache, Fever, Sore Throat
Minor Aches & Pains
Nasal/Sinus Congestion & Sinus Pressure
Cough
Chest Congestion

DayQuil Severe ONE 12 FL OZ (354 ml) BOTTLE:
TOTAL 24 FL

NyQuil^®
SEVERE