VICKS ALCOHOL FREE NYQUIL COLD AND FLU NIGHTTIME RELIEF - acetaminophen, chlorpheniramine maleate and dextromethorphan hydrobromide liquid
Procter & Gamble Manufacturing Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredients (in each 30 mL dose cup)	Purpose
Acetaminophen 650 mg	Pain reliever/fever reducer
Chlorpheniramine maleate 4 mg	Antihistamine
Dextromethorphan HBr 30 mg	Cough suppressant

Uses

temporarily relieves common cold/flu symptoms:

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

Warnings

Liver warning

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 daily while using this product

Sore throat warning

If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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.
to make a child sleep

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
a sodium-restricted diet

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

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.

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

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 & 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 6 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 insure correct dosing

Other information

each 30 mL dose cup contains: potassium 7 mg, sodium 47 mg
store at room temperature

Inactive ingredients

acesulfame potassium, carboxymethylcellulose sodium, citric acid, FD&C Red No. 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate

Questions?

1-800-362-1683

Dist. by
Procter & Gamble,
Cincinnati OH 45202.

PRINCIPAL DISPLAY PANEL - 360 ml Bottle Label

VICKS®

Alcohol Free
NyQuil®

COLD & FLU

Nighttime Relief

Acetaminophen, Chlorpheniramine, Dextromethorphan

Aches, Fever & Sore Throat
Sneezing, Runny Nose
Cough

May cause marked drowsiness

12 FL OZ
(360 ml)

PRINCIPAL DISPLAY PANEL - 360 ml Bottle Label

VICKS ALCOHOL FREE NYQUIL COLD AND FLU NIGHTTIME RELIEF
acetaminophen, chlorpheniramine maleate, and dextromethorphan hydrobromide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37000-699
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (Acetaminophen)	Acetaminophen	325 mg in 15 mL
Chlorpheniramine maleate (Chlorpheniramine)	Chlorpheniramine maleate	2 mg in 15 mL
Dextromethorphan Hydrobromide (Dextromethorphan)	Dextromethorphan Hydrobromide	15 mg in 15 mL

Inactive Ingredients
Ingredient Name	Strength
acesulfame potassium
carboxymethylcellulose sodium
citric acid monohydrate
FD&C Red No. 40
high fructose corn syrup
polyethylene glycols
propylene glycol
water
saccharin sodium
sodium benzoate
sodium citrate

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:37000-699-08	240 mL in 1 BOTTLE, PLASTIC	None
2	NDC:37000-699-12	360 mL in 1 BOTTLE, PLASTIC	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/01/2010

Labeler - Procter & Gamble Manufacturing Company (004238200)

Revised: 06/2011 Procter & Gamble Manufacturing Company