VICKS NYQUIL D COLD AND FLU NIGHTTIME RELIEF- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and pseudoephedrine hydrochloride liquid 
The 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 NyQuil D

Cold & Flu Nighttime Relief

Drug Facts

Active ingredients
(in each 30 mL dose cup)
Purpose
Acetaminophen 1000 mgPain reliever/fever reducer
Dextromethorphan HBr 30 mgCough suppressant
Doxylamine succinate 12.5 mgAntihistamine
Pseudoephedrine HCl 60 mgNasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

Warnings

Liver warning

This product contains acetaminophen. The maximum daily amount for this product is 3 doses (3,000 mg acetaminophen) in 24 hours.

Severe liver damage may occur if you take:

  • more than 4 doses (4,000 mg acetaminophen) in 24 hours
  • 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
  • thyroid disease
  • diabetes
  • glaucoma
  • high blood pressure
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

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 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 3 doses per 24 hrs
adults & children 12 yrs & over30 mL (2 TBSP) 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 ensure correct dosing

Other information

  • each 30 mL dose cup contains: sodium 38 mg
  • store at 20°-25°C (68°-77°F)

Inactive ingredients

alcohol, anethole, citric acid, D&C Yellow No. 10, FD&C Green No. 3, FD&C Yellow No. 6, 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.

PRINCIPAL DISPLAY PANEL - 295 mL Bottle Label

MAXIMUM
STRENGTH

VICKS®

NyQuil® D

COLD & FLU
Nighttime Relief

Acetaminophen, Dextromethorphan HBr, Doxylamine succinate,
Pseudoephedrine HCl

  • Minor Aches & Pains, Fever & Sore Throat
  • Cough
  • Sneezing, Runny Nose
  • Nasal Congestion

Alcohol 10%

10 FL OZ
(295 ml)

PRINCIPAL DISPLAY PANEL - 295 mL Bottle Label
VICKS NYQUIL D  COLD AND FLU NIGHTTIME RELIEF
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-654
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN1000 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
ANETHOLE (UNII: Q3JEK5DO4K)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorANISEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-654-10195 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/17/201204/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/17/201204/01/2016
Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 10/2016
 
The Procter & Gamble Manufacturing Company