Label: CONRX SINUS- acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 11, 2013

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  • Drug Facts

  • 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

    When using this product do not exceed recommended dosage

    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.

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

    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

    • Acetaminophen
      Headache & Pain
    • Guaifenesin
      Chest Congestion
    • Phenylephrine HCl
      Nasal Congestion

    TO OPEN
    PUSH IN TAB AND PULL OUT

    Compare to the Active Ingredients in

    Tylenol®Sinus*
    Congestion & Pain*

    50 Pouches of 2 Caplets Each

    Principal Display Panel - 2 Caplets × 50 Pouch Box
  • INGREDIENTS AND APPEARANCE
    CONRX SINUS 
    acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68737-236
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen325 mg
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin200 mg
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride5 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BIS(1-METHYLAMYL) SODIUM SULFOSUCCINATE (UNII: 772Y8KZU65)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    GELATIN (UNII: 2G86QN327L)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeOVALSize18mm
    FlavorImprint Code CRX
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68737-236-2050 in 1 BOX
    12 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34102/15/2013
    Labeler - Eagle Distributors,Inc. (929837425)
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