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


VICKS® NyQuil® COLD & FLU

VICKS NYQUIL COLD AND FLU NIGHTTIME RELIEF - acetaminophen, dextromethorphan hydrobromide and doxylamine succinate 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®
NyQuil®
COLD & FLU

Drug Facts

Active ingredients
(in each 30 mL dose cup)
Purpose
Acetaminophen 650 mg Pain reliever/fever reducer
Dextromethorphan HBr 30 mg Cough suppressant
Doxylamine succinate 12.5 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 30 mL dose cup contains: sodium 43 mg
  • store at room temperature

Inactive ingredients

alcohol, citric acid, D&C Yellow No. 10, FD&C Green No. 3, FD&C Yellow No. 6, flavor, high fructose corn syrup, PEG-40 stearate, polyethylene glycol, povidone, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, xanthan gum

Questions?

1-800-362-1683

Dist. by
Procter & Gamble,
Cincinnati OH 45202.

PRINCIPAL DISPLAY PANEL - 360 ml Bottle Label

50% MORE
than our
8 oz size

VICKS®

NyQuil®

COLD & FLU

Nighttime Relief

Acetaminophen, Doxylamine, Dextromethorphan

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

Alcohol 10%

TAMPER EVIDENT: Do not use if printed
shrinkband is missing or broken.

12 FL OZ
(360 ml)

PRINCIPAL DISPLAY PANEL - 360 ml Bottle Label

VICKS NYQUIL  COLD AND FLU NIGHTTIME RELIEF
acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-807
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
alcohol  
citric acid monohydrate  
D&C Yellow No. 10  
FD&C Green No. 3  
FD&C Yellow No. 6  
high fructose corn syrup  
PEG-40 stearate  
polyethylene glycols  
povidone  
propylene glycol  
water  
saccharin sodium  
sodium benzoate  
sodium citrate  
xanthan gum  
Product Characteristics
Color GREEN Score     
Shape Size
Flavor ANISE, MENTHOL Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:37000-807-08 240 mL in 1 BOTTLE, PLASTIC None
2 NDC:37000-807-12 360 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: 06/2011 Procter & Gamble Manufacturing Company



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


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