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  5. Label Information: Nuvicare Nighttime Cold And Flu Softgel

FDA Label for Nuvicare Nighttime Cold And Flu Softgel

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENTS (IN EACH SOFTGEL)
    3. PURPOSE
    4. USES:
    5. WARNING
    6. DO NOT USE:
    7. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENTS
    10. QUESTIONS OR COMMENTS?

Nuvicare Nighttime Cold And Flu Softgel Product Label

The following document was submitted to the FDA by the labeler of this product Nuvicare Llc. 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.

Drug Facts




Active Ingredients (In Each Softgel)



Acetaminophen 325mg

Dextromethorphan HBr 15mg

Doxylamine succinate 6.25 mg


Purpose



Acetaminophen 325mg.....................Pain reliever/fever reducer
Dextromethorphan HBr 15mg..................... Cough suppressant
Doxylamine succinate 6.25 mg ............................. Antihistamine


Uses:



temporarily relieves these common cold/flu symptoms:
■ minor aches & pains

■ headache

■ sore throat

■ fever

■ Runny nose and sneezing

■ cough due to minor throat & bronchial irritation


Warning



Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
■ more than 8 softgels in 24 hours, which is the maximum daily amount for this product ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks everyday while using this product.

Allergy Alert: acetamenophen may cause severe skin recations. Symptoms may include:

■ skin reddening ■ blisters ■ rash. if a skin reactions 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:



  • 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.
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist 

Directions



■ take only as directed- see OVERDOSE WARNING

■ do not exceed 8 softgels per 24 hrs. 

■ take softgels with water

 Adults and children age 12 yrs and over2 softgels every 6 hrs. 
 Children 4 to under 12 yrs  ask a doctor
 Children under 4 yrs do not use


Other Information



■ store between 15-30°C (59 to 86 °F)

■ avoid excessive heat


Inactive Ingredients



Polyethylene Glycol400, Propylene Glycol, Povidone K-30,Purified water, Gelatin, Glycerin, Sorbitol Sorbitan solution, FD & C Blue No. 1, D &C Yellow No.10


Questions Or Comments?



Call 1-718-337-8733 or email: [email protected]


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