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  5. Label Information: Vicks Nyquil-d Cold And Sinus Plus Severe Congestion

FDA Label for Vicks Nyquil-d Cold And Sinus Plus Severe Congestion

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENTS (IN EACH LIQUICAP)
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    9. WHEN USING THIS PRODUCT
    10. STOP USE AND ASK A DOCTOR IF
    11. IF PREGNANT OR BREAST-FEEDING,
    12. OTC - KEEP OUT OF REACH OF CHILDREN
    13. OVERDOSAGE
    14. DIRECTIONS
    15. OTHER INFORMATION
    16. INACTIVE INGREDIENTS
    17. QUESTIONS?
    18. PRINCIPAL DISPLAY PANEL - 12 LIQUICAPS™

Vicks Nyquil-d Cold And Sinus Plus Severe Congestion 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

TAMPER EVIDENT: DO NOT USE IF SEAL UNDER CAP IS MISSING OR DAMAGED.

DIST. BY PROCTER & GAMBLE,

CINCINNATI, OH 45202


Active Ingredients (In Each Liquicap)



Acetaminophen 500 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Pseudoephedrine HCl 30 mg


Purpose



Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant


Uses



temporarily relieves common cold/flu symptoms:

  • nasal congestion 
  • sinus
  • congestion & pressure 
  • cough due to minor throat & bronchial irritation 
  • cough to help you sleep 
  • minor aches & pains 
  • headache 
  • fever 
  • sore throat
  • runny nose & sneezing 
  • reduces swelling of nasal passages 
  • temporarily
  • restores freer breathing through the nose 
  • promotes nasal and/or sinus drainage

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
  • 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

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.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Directions



  • take only as directed
  • do not exceed 6 LiquiCaps per 24 hrs
    • adults & children 12 yrs & over2 LiquiCaps with water every 6 hrs
    children under 12 yrsdo not use


Other Information



  • store at no greater than 25° C (77°F)

Inactive Ingredients



1,4-Sorbitan, alcohol, ammonia, D&C Yellow No. 10, ethyl acetate, FD&C Blue No. 1, gelatin, glycerin, Isopropyl alcohol, mannitol, mica,
polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, sorbitol, titanium dioxide, water


Questions?



1-800-362-1683


Principal Display Panel - 12 Liquicaps™



VICKS®

NyQuil-D

COLD & SINUS

+ SEVERE CONGESTION

Acetaminophen - Pain reliever/fever reducer

Pseudoephedrine HCl - Nasal decongestant

Doxylamine succinate - Antihistamine

Dextromethorphan HBr - Cough suppressant

12 LIQUICAPS™

364 - 364

364 - 364


* Please review the disclaimer below.