Label: ALLERGY RELIEF MULTISYMPTOM- acetaminophen,chlorpheniramine maleate, phenylephrine hcl tablet, coated

  • Category: HUMAN OTC DRUG LABEL

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 October 15, 2012

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  • ACTIVE INGREDIENT

    Active Ingredients

    Acetaminophen 325 mg.......................Pain Reliever/Fever Reducer
    Chlorpheniramine Maleate 2 mg.............................Antihistamine
    Phenylephrine HCl 5 mg.............................Nasal Decongestant



  • PURPOSE

    Pain Reliever, Fever Reducer, Antihistamine, Nasal Decongestant

  • DOSAGE & ADMINISTRATION

    Directions: Adults and children 12 years of age and older • take 2
    tablets every 4 to 6 hours as needed, do not exceed 8 tablets in 24 hours, or
    as directed by a doctor • Children under 12 years, consult a doctor

  • INDICATIONS & USAGE

    Uses: Temporarily: • relieves nasal congestion associated with sinusitis
    • relieves nasal congestion due to the common cold, hay fever or other
    upper respiratory allergies • relieves sinus congestion and pressure,
    helps decongest sinus openings and passages • restores free breathing
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the
    bronchial passages of bothersome mucus, drain bronchial tubes, and
    make coughs more productive • Temporarily relieves minor aches, pains,
    and fever associated with: • headache • common cold • toothache
    • backache • muscular aches • menstrual cramps

  • WARNINGS

    Warnings: Liver Warning: This
    product contains acetaminophen. Severe liver damage may occur if
    you take: • more than 8 tablets in 24 hours • with other drugs containing
    acetaminophen (prescription or nonprescription). Ask a doctor or
    pharmacist before using with other drugs if you are not sure. • 3 or more
    alcoholic drinks every day while using this product Do not: use with
    any other product containing acetaminophen this will provide more
    than the recommended dose (overdose) of acetaminophen and could
    cause serious health concerns. • use more than the recommended
    dose • for more than 10 days for pain unless directed by a doctor • for
    more than 3 days for fever unless directed by a doctor • 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 MAOI drug. If you do not know if your prescription
    drug contains an MAOI, consult a doctor or pharmacist before
    taking this product. Stop use and ask a doctor if: • symptoms
    do not improve • pain or fever persists or gets worse • new
    symptoms occur • redness or swelling is present • nervousness,
    dizziness or sleeplessness occur • symptoms do not improve within 7
    days or are accompanied by fever Ask a doctor before use if you
    have: • heart disease • high blood pressure • thyroid disease • diabetes
    • difficulty in urination due to enlargement of the prostate gland • a breathing
    problem such as emphysema or chronic bronchitis, or if you have glaucoma
    or difficulty in urination due to enlargement of the prostate gland • may cause
    excitability especially in children • may cause drowsiness; alcohol, sedatives,
    and tranquilizers may increase the drowsiness effect • avoid alcoholic
    beverages while taking this product • do not take this product if you are
    taking sedatives or tranquilizers, without first consulting your doctor • use
    caution when operating machinery.
  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • INACTIVE INGREDIENT

    Inactive ingredients: FDC Red 40,
    Maltodextrin, Microcrystalline Cellulose, Povidone, Sodium Starch
    Glycolate, Starch, Stearic Acid

  • PRINCIPAL DISPLAY PANEL

    MM1

    allergy multi symptom packet

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF MULTISYMPTOM  
    acetaminophen,chlorpheniramine maleate, phenylephrine hcl tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52904-457
    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
    POVIDONE K29/32 (UNII: 390RMW2PEQ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Colorwhite (snow white) Scoreno score
    ShapeROUND (FR11) Size11mm
    FlavorImprint Code FR11
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52904-457-022 in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/15/2012
    Labeler - Select Corporation (053805599)