Label: CONRX PAIN RELIEVER SINUS HEADACHE- phenylephrine hydrochloride and acetaminophen 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 7, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each caplet)Purposes
    Acetaminophen 325 mgPain reliever
    Phenylephrine HCl 5 mgNasal decongestant
  • Uses

    • temporarily relieves:
      • headache
      • minor aches and pains
      • nasal congestion
      • sinus congestion and pressure
      • helps clear nasal passages; shrinks swollen membranes
  • Warnings

    Liver Warning

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

    • more than 12 caplets in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Do not use

    • if you are allergic to acetaminophen
    • 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

    Ask a doctor before use if you have

    • liver disease
    • heart disease
    • thyroid disease
    • trouble urinating due to an enlarged prostate gland
    • high blood pressure
    • diabetes

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin

    When using this product

    • do not use more than directed

    Stop use and ask a doctor if

    • any new symptoms occur
    • you get nervous, dizzy, or sleepless
    • painful area is red or swollen
    • pain or nasal congestion gets worse or lasts for more than 7 days
    • fever gets worse or lasts for more than 3 days

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

    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 use more than directed
    • adults and children 12 years and over: take 2 caplets every 4 hours; not more than 12 caplets in 24 hours
    • children under 12 years: ask a doctor
  • Other information

    • store at controlled room temperature 20°-25°C (68°-77°F)
    • read all product information before using. Keep this box for important information.
  • Inactive ingredients

    benzoic acid, carnauba wax, corn starch, FD&C blue # 1, light mineral oil, magnesium stearate, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, stearic acid, titanium dioxide, talc,gelatin, polyethylene glycol sodium starch glycolate, sodium benzoate, hydroxypropylmethyl cellulose

  • Questions or comments?

    1-855-619-7900

  • PRINCIPAL DISPLAY PANEL - 50 x 2 Caplet Pouch Box

    See New Warnings Information & Directions
    Compare to the Active Ingredients in
    EXCEDRIN*® SINUS
    HEADACHE

    ConRx®

    PAIN RELIEVER
    SINUS
    HEADACHE

    Acetaminophen and Phenylephrine HCl

    Aspirin Free • Pain Reliever / Nasal Decongestant

    TO OPEN
    PUSH IN TAB AND PULL OUT

    Compare to the Active Ingredients in
    EXCEDRIN® SINUS
    HEADACHE

    2 Caplets Each Pouch

    Principal Display Panel - 50 x 2 Caplet Pouch Box
  • INGREDIENTS AND APPEARANCE
    CONRX PAIN RELIEVER SINUS HEADACHE 
    phenylephrine hydrochloride and acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68737-240
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride5 mg
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen325 mg
    Inactive Ingredients
    Ingredient NameStrength
    Benzoic Acid (UNII: 8SKN0B0MIM)  
    Carnauba Wax (UNII: R12CBM0EIZ)  
    Starch, Corn (UNII: O8232NY3SJ)  
    Fd&C Blue No. 1 (UNII: H3R47K3TBD)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    light mineral oil (UNII: N6K5787QVP)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Cellulose, Microcrystalline (UNII: OP1R32D61U)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Povidones (UNII: FZ989GH94E)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Polyethylene Glycols (UNII: 3WJQ0SDW1A)  
    Stearic acid (UNII: 4ELV7Z65AP)  
    Titanium dioxide (UNII: 15FIX9V2JP)  
    Talc (UNII: 7SEV7J4R1U)  
    Gelatin (UNII: 2G86QN327L)  
    Sodium Starch Glycolate Type A Corn (UNII: AG9B65PV6B)  
    Hypromelloses (UNII: 3NXW29V3WO)  
    Product Characteristics
    ColorBLUEScore2 pieces
    ShapeOVALSize18mm
    FlavorImprint Code CRX
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68737-240-2450 in 1 BOX
    12 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/31/2014
    Labeler - Eagle Distributors,Inc. (929837425)
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