FDA Label for Vicks Nyquil Cold And Flu

View Indications, Usage & Precautions

Vicks Nyquil Cold And Flu Product Label

The following document was submitted to the FDA by the labeler of this product The Procter & Gamble Manufacturing Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients (In Each 30 Ml)




Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg


Purpose




Pain reliever/fever reducer

Cough suppressant

Antihistamine


Uses



temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • cough to help you sleep
  • sore throat
  • headache
  • minor aches and pains
  • fever
  • runny nose and sneezing

Liver Warning:



This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4 doses (30 mL each dose) 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

Allergy Alert:



Acetaminophen may cause severe skin reactions.

Symptoms may include:

  • skin reddening
  • blisters
  • rash
  • If a skin reaction occurs, stop use and seek medical help right away


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
  • 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

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.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Inactive Ingredients



alcohol, anhydrous citric acid, D&C Yellow No. 10, FD&C Green No. 3, FD&C Yellow No. 6, flavor, glycerin, propylene glycol, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, sucralose, water, xanthan gum


Questions?



1-800-362-1683


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