FDA Label for Vicks Nyquil Ultra Concentrated Cold And Flu

View Indications, Usage & Precautions

Vicks Nyquil Ultra Concentrated 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.

Other



Drug Facts

DIST. BY PROCTER & GAMBLE,

CINCINNATI, OH 45202


Active Ingredients (In Each Liquicap)



Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg


Active Ingredients (In Each Liquicap) Purpose



Pain reliever/fever reducer
Cough suppressant
Antihistamine


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 8 Liquicaps 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


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.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Directions



  • take only as directed
  • do not exceed 8 LiquiCaps per 24 hrs
  • adults & children 12 yrs & over2 LiquiCaps with water every 4 hrs
    children 4 to under 12 yrsask a doctor
    children under 4 yrsdo not use


Other Information



  • store at no greater than 25° C

Inactive Ingredients



Inactive Ingredients D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, lecithin, mica, polyethylene glycol, polyvinyl acetate phthalate, povidone, sorbitol sorbitan solution, titanium dioxide, water


Questions?



1-800-362-1683


Principal Display Panel - 48 Liquicaps™



MAX STRENGTH

100% MORE LIQUICAPS†

VICKS®

NyQuil™

ULTRA CONCENTRATED

COLD & FLU

Acetaminophen, Doxylamine Succinate, Dextromethorphan HBr

Headache, Fever, Sore Throat, Minor Aches & Pains
Sneezing, Runny Nose
Cough

25% SMALLER*

EASY TO SWALLOW

Nighttime Relief

48 LIQUICAPS™


* Please review the disclaimer below.