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  5. Label Information: Night-time Cold And Flu Relief

FDA Label for Night-time Cold And Flu Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH SOFTGELS)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. KEEP OUT OF REACH OF CHILDREN
    6. DIRECTION
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS
    9. QUESTIONS OR COMMENTS?
    10. DISTRIBUTED BY:
    11. PACKAGE LABEL

Night-time Cold And Flu Relief Product Label

The following document was submitted to the FDA by the labeler of this product Healthlife Of Usa. 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 Softgels)



Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg


Purpose



Pain reliever/Fever reducer
Cough suppressant
Antihistamine


Uses



temporarily relieves common cold/flu symptoms:

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

Warnings



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

  • more than 4 doses in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily 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, 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.

        • 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

            • excitability may occur, especially in children
            • marked drowsiness may occur
            • avoid alcoholic drink
            • 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.


Keep Out Of Reach Of Children



In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as
for children even if you do not notice any signs or symptoms.


Direction



  • take only as directed
  • do not exceed 4 doses per 24 hours
    •  adults & children 12 yrs & over 2 softgels with water every 6 hrs
     children 4 to under 12 yrs ask a doctor
     children under 4 yrs do not use


Other Information



  • store at room temperature.
  • TAMPER EVIDENT: This package is safety sealed & child resistant. Use only if blisters are intact. If difficult to open, use scissors.
  • KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Inactive Ingredients



D&C Yellow No.10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide, methyl paraben, propyl paraben.


Questions Or Comments?



1-844-832-1138

M-F 9am-5pm EST


Distributed By:



Health life of USA LLC
Rahway, NJ 07065
www.healthlifeus.com

*This product is not manufactured or distributed by Procter & Gamble, Distributor of Vicks Nyquil ®


Package Label



NDC 69517-161-10

10 Softgels

Night-Time Cold & Flu Relief

Acetaminophen, Doxylamine Succinate, Dextromethorphan HBr

* Please review the disclaimer below.