Vicks NyQuil Cold and Flu

Dosage form: capsule, liquid filled
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 15mg, DOXYLAMINE SUCCINATE 6.25mg
Labeler: Mechanical Servants, Inc.
NDC Code: 29485-2828

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.

Vicks®
NyQuil® Cold and Flu

Drug Facts

Active ingredients
(in each LiquiCap)
Purpose
Acetaminophen 325 mgPain reliever/
fever reducer
Dextromethorphan HBr 15 mgCough suppressant
Doxylamine succinate 6.25 mgAntihistamine

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 hrs, 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

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
  • do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over2 LiquiCaps with water every 6 hrs
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use
  • when using other DayQuil® or NyQuil products, carefully read each label to insure correct dosing

Other information
  • store at room temperature

Inactive ingredients

D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, titanium dioxide

Questions?

1-800-362-1683

Manufactured by Procter & Gamble
Cincinnati OH 45202

Distributed by Convenience Valet®
Melrose Park, IL 60160

PRINCIPAL DISPLAY PANEL - 2 Capsule Pouch Package

CONVENIENCE
CV
VALET
®

COLD
RELIEF

VICKS®
NyQuil®

2 LiquiCaps®

VICKS NYQUIL   COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-2828(NDC:37000-557)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE6.25 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
POVIDONE 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
TITANIUM DIOXIDE 
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize21mm
FlavorImprint CodeNQUIL
Contains    
Packaging
#Item CodePackage Description
1NDC:29485-2828-51 POUCH (POUCH) in 1 PACKAGE
12 CAPSULE, LIQUID FILLED (CAPSULE) in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/2010
Labeler - Mechanical Servants, Inc. (005530951)
Establishment
NameAddressID/FEIOperations
Mechanical Servants, Inc.005530951RELABEL

Revised: 01/2012
 
Mechanical Servants, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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