VICKS DAYQUIL AND VICKS NYQUIL SEVERE COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and doxylamine succinate   
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® DayQuil® and Vicks® NyQuil®
Severe Cold and Flu

DayQuil Severe Cold & Flu

Drug Facts

Active ingredients (in each 15 mL tablespoon)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant

Uses

Warnings

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

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.

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

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

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.

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 as well as for children even if you do not notice any signs or symptoms.

Directions

adults & children 12 yrs & over30 mL (2 TBSP) every 4 hrs
children 6 to under 12 yrs15 mL (1 TBSP) every 4 hrs
children 4 to under 6 yrsask a doctor
children under 4 yrsdo not use

Other information

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

Questions?

1-800-251-3374

NyQuil Severe Cold & Flu

Drug Facts

Active ingredients (in each 30 mL dose cup)Purpose
Acetaminophen 650 mgPain reliever/fever reducer
Dextromethorphan HBr 20 mgCough suppressant
Doxylamine succinate 12.5 mgAntihistamine
Phenylephrine HCl 10 mgNasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

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, 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.
  • to make a child sleep

Ask a doctor before use if you have

  • 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

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

  • 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.

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 as well as for children even if you do not notice any signs or symptoms.

Directions

adults & children 12 yrs & over30 mL (2 TBSP) every 4 hrs
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use

Other information

Inactive ingredients

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?

1-800-362-1683

Dist. by Proctor & Gamble, Cincinnati OH 45202

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

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

NyQuil®
SEVERE

COLD & FLU

Nighttime Relief

Acetaminophen, Phenylephrine HCl, Doxylamine Succinate,
Dextromethorphan HBr

MAX
STRENGTH

Berry Flavor

NyQuil Severe ONE 12 FL OZ (354 ml) BOTTLE
OZ (708 ml)

PRINCIPAL DISPLAY PANEL - Kit Carton
VICKS DAYQUIL AND VICKS NYQUIL  SEVERE COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and doxylamine succinate kit
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:37000-814
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-814-241 in 1 PACKAGE
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 354 mL
Part 21 BOTTLE, PLASTIC 354 mL
Part 1 of 2
VICKS DAYQUIL   SEVERE COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride liquid
Product Information
Item Code (Source)NDC:37000-810
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen325 mg  in 15 mL
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide10 mg  in 15 mL
Guaifenesin (Guaifenesin) Guaifenesin200 mg  in 15 mL
Phenylephrine Hydrochloride (phenylephrine) Phenylephrine Hydrochloride5 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
citric acid monohydrate 
FD&C Yellow No. 6 
glycerin 
propylene glycol 
water 
saccharin sodium 
sodium benzoate 
sodium chloride 
sodium citrate 
sorbitol 
sucralose 
xanthan gum 
Product Characteristics
ColorORANGEScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-810-12354 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/22/2013
Part 2 of 2
VICKS NYQUIL   SEVERE COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride liquid
Product Information
Item Code (Source)NDC:37000-812
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen650 mg  in 30 mL
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide20 mg  in 30 mL
Doxylamine Succinate (DOXYLAMINE) Doxylamine Succinate12.5 mg  in 30 mL
Phenylephrine Hydrochloride (phenylephrine) Phenylephrine Hydrochloride10 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
citric acid monohydrate 
FD&C Blue No. 1 
FD&C Red No. 40 
glycerin 
propylene glycol 
water 
saccharin sodium 
sodium benzoate 
sodium chloride 
sodium citrate 
sorbitol 
sucralose 
xanthan gum 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-812-12354 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/22/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/22/2013
Labeler - Procter & Gamble Manufacturing Company (004238200)

Revised: 6/2013
Document Id: 3d4e418a-b1fa-403a-929c-eb90f516793c
Set id: a17d0de4-85d1-47b7-ba72-3672ea65b397
Version: 1
Effective Time: 20130620
 
Procter & Gamble Manufacturing Company