1. Home
  2. Labeler Index
  3. Eagle Distributors,inc.
  4. 68737-227
  5. Label Information: Conrx Cold

FDA Label for Conrx Cold

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH TABLET)
    3. PURPOSE
    4. USES
    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 - 50 POUCH CARTON

Conrx Cold 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.

Other



Drug Facts

  • Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 12 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
  • 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.

    • Product manufactured for:
    Eagle Distributors, Inc.
    Los Angeles, CA 90011


Active Ingredient (In Each Tablet)



Acetaminophen 325mg

Dextromethorphan HBr 10 mg

Guaifenesin 200mg

Phenylephrine HCl 5mg


Purpose



Pain reliever/ fever reducer

Cough Suppressant

Expectorant

Nasal decongestant


Uses



  • for the temporary relief of the following cold symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • nasal congestion
    • cough
    • sinus congestion and pressure
    • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

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



  • Do not take more than directed
    • Adults and Children 12 years and over
    • Take 2 tablets with water every 6-8 hours as needed
    • Do not take 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 20-25°C (68-77°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, D & C yellow #10 aluminium lake ,Titanium Dioxide.


Principal Display Panel - 50 Pouch Carton



NDC: 68737-227-11

Compare to the Active Ingredients in
Tylenol ® Cold
Head Congestion*

ConRx
COLD
SEVERE Sore throat -Cough - Headache

  • Acetaminophen                          Sore throat
  • Dextromethorphan HBr             Cough
  • Guaifenesin                                 Chest Congestion
  • Phenylephrine HCl                     Nasal Congestion

    • TO OPEN
    PUSH IN TAB AND PULL OUT

    Compare to the Active Ingredients in
    Tylenol    ®Cold
    Head Congestion*

    50 Pouches of 2 Caplets Each

    Principal Display Panel - 50 Pouch Carton - conrx 01

    Principal Display Panel - 50 Pouch Carton - conrx 01


* Please review the disclaimer below.