VICKS NYQUIL COLD AND FLU NIGHTTIME RELIEF - acetaminophen, dextromethorphan hydrobromide and doxylamine succinate liquid 
Procter & Gamble Manufacturing Company

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VICKS®
NyQuil®
COLD & FLU Nighttime Relief

Drug Facts

Active ingredients (in each 15 ml TBSP)	Purpose
Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan HBr 15 mg	Cough suppressant
Doxylamine succinate 6.25 mg	Antihistamine

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 every day 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 the recommended dose 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 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 tablespoon contains: potassium 5 mg, sodium 19 mg
• store at room temperature

Inactive ingredients

acesulfame potassium, alcohol, citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions?

1-800-362-1683

Dist. by Procter & Gamble,
Cincinnati OH 45202.

www.vicks.com

PRINCIPAL DISPLAY PANEL - 295 mL Bottle Label

VICKS®

NyQuil®

COLD & FLU Nighttime Relief

Acetaminophen, Doxylamine, Dextromethorphan

• Aches, Fever, Sore Throat
• Sneezing, Runny Nose
• Cough

10 FL OZ (295 ml)
Alcohol 10%
See new warnings and dosing information.

VICKS NYQUIL  COLD AND FLU NIGHTTIME RELIEF acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate   liquid

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 37000-808 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (Acetaminophen) Acetaminophen 325 mg  in 15 mL Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide 15 mg  in 15 mL Doxylamine succinate (Doxylamine) Doxylamine succinate 6.25 mg  in 15 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color RED Score      Shape Size Flavor CHERRY, MENTHOL Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 37000-808-06 177 mL In 1 BOTTLE, PLASTIC None 2 37000-808-10 295 mL In 1 BOTTLE, PLASTIC None 3 37000-808-12 354 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: 06/2010Procter & Gamble Manufacturing Company