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Name:Vicks Alcohol Free Nyquil Cold And Flu Nighttime Relief
Manufacturer:Procter & Gamble Manufacturing Company
Category:Over-the-counter (OTC) Marketed Drugs


VICKS® Alcohol Free NyQuil® COLD & FLU Nighttime Relief

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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VICKS®
Alcohol Free
NyQuil®
COLD & FLU Nighttime Relief

Drug Facts

Active ingredients (in each 15 ml TBSP) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Chlorpheniramine maleate 2 mg Antihistamine
Dextromethorphan HBr 15 mg 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 & 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, & 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 tablespoon contains: potassium 5 mg, sodium 24 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.

www.vicks.com

PRINCIPAL DISPLAY PANEL - 295 ml Bottle Label

VICKS®

Alcohol Free
NyQuil
®

COLD & FLU Nighttime Relief

Acetaminophen, Chlorpheniramine, Dextromethorphan

Aches, Fever, Sore Throat
Sneezing, Runny Nose
Cough

10 FL OZ (295 ml)

May cause marked drowsiness
See new warnings information.

PRINCIPAL DISPLAY PANEL - 295 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
Product Characteristics
Color RED Score     
Shape Size
Flavor BERRY Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:37000-699-06 177 mL in 1 BOTTLE, PLASTIC None
2 NDC:37000-699-10 295 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: 06/2010 Procter & Gamble Manufacturing Company



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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