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  5. Label Information: Conrx Sinus

FDA Label for Conrx Sinus

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH TABLET)
    2. PURPOSE
    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. STOP USE AND ASK A DOCTOR IF
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. OVERDOSE WARNING
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. PRINCIPAL DISPLAY PANEL - 2 CAPLETS × 50 POUCH BOX

Conrx Sinus Product Label

The following document was submitted to the FDA by the labeler of this product Eagle Distributors,inc.. 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 Tablet)



Acetaminophen 325mg

Guaifenesin 200mg

Phenylephrine HCl 5mg


Purpose



Pain reliever/ fever reducer

Expectorant

Nasal decongestant


Uses



Uses For the temporary relief of: sinus congestion and pressure, headache, nasal congestion, minor aches and pains, helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive, temporarily relieves nasal congestion due to the common cold, and hay fever and other upper respiratory allergies.


Warnings



  • Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 8 tablets 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

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

Ask A Doctor Before Use If You Have



  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • a persistent chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)

Ask A Doctor Or Pharmacist Before Use If You Are



  • taking the blood thinning drug warfarin

Stop Use And Ask A Doctor If



  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion or cough gets worse or lasts for more than 7 days
  • fever gets 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 serious conditions.

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Overdose Warning



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


Directions



Adults and Children 12 years and over
  • Take 1-2 tablets every 4 hours as needed
  • Do not taking more than 8 tablets in 24 hour
Children under 12 years of ageConsult a doctor

Other Information



  • Do not use if pouch is torn or damaged.
  • Store between 15-30°C (59-86°F). Avoid excessive heat and humidity.
  • See side panel for lot number and expiration date.

Inactive Ingredients



Colloidal silicon dioxide, Sodium Lauryl Sulphate, Edetaet disodium, dioctyl sodium sulphosuccinate, polyvinyl pyrollidone, gelatin, corn starch', magnesium Stearate, microcrystalline cellulose, polyethylene glycol 6000,Sodium Benzoate ,Sodium Starch Glycolate, Stearic acid, Purified Talc, Titanium Dioxide.


Principal Display Panel - 2 Caplets × 50 Pouch Box



See New Warnings Information & Directions

Compare to the Active Ingredients in

Tylenol®Sinus*

Congestion & Pain*

ConRx™

SEVERE
SINUS

Headache & Nasal Congestion

* Please review the disclaimer below.