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  5. Label Information: Gencare Daytime Cold And Flu Softgel

FDA Label for Gencare Daytime Cold And Flu Softgel

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH SOFTGEL)
    2. PURPOSE
    3. USES:
    4. WARNING
    5. DO NOT USE:
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS
    9. QUESTIONS OR COMMENTS?
    10. NDC 72090-005-01- 48 SOFTGELS

Gencare Daytime Cold And Flu Softgel Product Label

The following document was submitted to the FDA by the labeler of this product Pioneer Life Sciences, 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.

Active Ingredients (In Each Softgel)



Acetaminophen 325mg

Dextromethorphan HBr 10mg

Phenylephrine HCl 5mg


Purpose



Acetaminophen 325mg.....................Pain reliever/fever reducer
Dextromethorphan HBr 10mg..................... Cough suppressant
Phenylephrine HCl 5mg ............................. Nasal decongestant


Uses:



temporarily relieves common cold/flu symptoms:
■ nasal congestion

■ cough due to minor throat & bronchial irritation

■ sore throat

■ headache

■ minor aches & pains

■ fever


Warning



Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
■ more than 4 doses in 24 hrs, which is the maximum daily amount for this product ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks daily while using this product.

Sore throat warning: If sore throat is severe, lasts 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.

Directions



■ take only as directed

■ do not exceed 4 doses per 24 hrs. 

 Adults and children 12 yrs and overtake 2 softgels with water every 4 hrs. 
 Children 4 to under 12 yrs  ask a doctor
 Children under 4 yrs do not use


Other Information



■ store at room temperature


Inactive Ingredients



Polyethylene Glycol400, Propylene Glycol, Povidone, Gelatin, Sorbitol Sorbitan Anhydrous, Glycerin, Allura Red, FD & C Yellow 6/Sunset Yellow, Titanium Dioxide.


Questions Or Comments?



Call 1-732-698-5070 Mon-Fri, 9am-5pm EST or visit: www.gencare.health.


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