Label: CONRX ALLERGY SINUS MULTI-SYMPTOMS- acetaminophen, chlorpheniramine maleate, 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 July 10, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Acetaminophen 325mg

    Chlorpheniramine maleate 2mg

    Phenylephrine HCl 5mg

  • Purpose

    Pain reliever/ fever reducer

    Antihistamine

    Nasal decongestant

  • Uses

    Uses For the temporary relieves these symptoms of hay fever or other upper respiratory allergies, headache, sinus congestion and pressure, nasal congestion, runny nose and sneezing ,minor aches and pains, itching of the nose or throat ,itchy watery eyes, help decongest sinus openings and passages.

  • 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 breathing problem such as emphysema or chronic bronchitis,
    • glaucoma

    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
    • excitability may occur, especially in children
    • drowsiness may occur
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • avoid alcoholic drinks
    • be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • pain 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

    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

    Do not taking more than directed (see overdose warning)

    Adults and Children 12 years and above
    • Take 1-2 tablets every 4 hours
    • 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, Polyvinylpyrollidone, Gelatin, Corn starch', Magnesium Stearate, Microcrystalline Cellulose, Polyethylene glycol 6000,Sodium Benzoate ,Sodium Starch Glycolate, Stearic acid, Purified Talc, Titanium Dioxide, Yellow iron oxide.

  • PRINCIPAL DISPLAY PANEL - 50 Pouch Carton

    NDC:68737-225-09

    Compare to the Active Ingredients in
    Tylenol®Allergy
    Multi-Symptom*

    ConRx
    Allergy MULTI - SYMPTOM
    Sinus
    Sneezing - Runny Nose - Congestion

     

    • Acetaminophen                      Headache
    • Phenylephrine HCl                    Sinus Pressure/Nasal Congestion
    • Chlorpheniramine Maleate       Watery Eyes/Runny Nose
    Principal Display Panel - 50 Pouch Carton
  • INGREDIENTS AND APPEARANCE
    CONRX   ALLERGY SINUS MULTI-SYMPTOMS
    acetaminophen, chlorpheniramine maleate, and phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68737-225
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen325 mg
    Chlorpheniramine maleate (UNII: V1Q0O9OJ9Z) (Chlorpheniramine - UNII:3U6IO1965U) Chlorpheniramine maleate2 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)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    GELATIN (UNII: 2G86QN327L)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    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)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeROUNDSize12mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68737-225-0950 in 1 BOX
    12 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34107/11/2012
    Labeler - Eagle Distributors,Inc. (929837425)
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