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  5. Label Information: Severe Sinus Congestion Allergy And Cough Formula

FDA Label for Severe Sinus Congestion Allergy And Cough Formula

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH SOFTGEL)
    2. PURPOSES
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PRINCIPAL DISPLAY PANEL

Severe Sinus Congestion Allergy And Cough Formula Product Label

The following document was submitted to the FDA by the labeler of this product Puracap Pharmaceutical 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 Ingredient (In Each Softgel)



Acetaminophen 325 mg

Dextromethorphan hydrobromide 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine hydrochloride 5 mg


Purposes



Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant


Uses



  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes
      • temporarily relieves these symptoms due to a cold:
        • nasal congestion
        • sinus congestion and pressure
        • headache
        • minor aches and pains
        • cough

          • temporarily reduces fever

Warnings



Liver warning

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

  • more than 10 softgels in 24 hrs, 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.

      Do not use to sedate children.


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.
  • if you have ever had an allergic reaction to this product or any of its ingredients
  • in children under 12 years of age

Ask A Doctor Before Use If You Have



  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • cough with excessive phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Ask A Doctor Or Pharmacist Before Use If You Are



  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When Using This Product



  • do not exceed recommended dosage
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Stop Use And Ask A Doctor If



  • pain, cough, or nasal congestion 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.
  • nervousness, dizziness, or sleeplessness occurs

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.


Directions



  • do not take more than the recommended dose
  • adults and children 12 years and over: take 2 softgelss with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor.
  • children under 12 years: do not use

Other Information



  • Store at room temperature. Avoid excessive heat.

Inactive Ingredients



D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol,  povidone, propylene glycol, purified water, sorbitol special, and white edible ink


Questions Or Comments?



Call: 1-888-309-9030


Principal Display Panel



DG Severe Sinus Congestion Allergy & Cough Formula 20 Softgels

*Compare to the active ingredients in Alka-Seltzer PLUS® Severe Sinus Congestion, Allergy & Cough

NDC 51013-169-08


* Please review the disclaimer below.