ALLERGY (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [L. PERRIGO COMPANY]

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ALLERGY (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [L. PERRIGO COMPANY]
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NDC 0113-2476-62
Set ID ba0f265b-73a0-46ef-ba59-fc3405091faa
Category HUMAN OTC DRUG LABEL
Packager L. Perrigo Company
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • Active ingredients (in each caplet)

    Acetaminophen 325 mg

    Chlorpheniramine maleate 2 mg

    Phenylephrine HCl 5 mg

  • Purpose

    Pain reliever

    Antihistamine

    Nasal decongestant

  • Uses

    •
    temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
    •
    runny nose and sneezing
    •
    nasal congestion
    •
    minor aches and pains
    •
    headache
    •
    sinus congestion and pressure
    •
    temporarily relieves these additional symptoms of hay fever:
    •
    itching of the nose or throat
    •
    itchy, watery eyes
    •
    helps clear nasal passages
    •
    helps decongest sinus openings and passages
  • Warnings

    Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take

    •
    more than 4,000 mg of acetaminophen in 24 hours
    •
    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
    •
    to make a child sleepy

    Ask a doctor before use if you have

    •
    liver disease
    •
    heart disease
    •
    diabetes
    •
    high blood pressure
    •
    thyroid disease
    •
    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
    •
    taking sedatives or tranquilizers

    When using this product

    •
    do not exceed recommended dosage
    •
    excitability may occur, especially in children
    •
    alcohol, sedatives, and tranquilizers may increase drowsiness
    •
    avoid alcoholic drinks
    •
    be careful when driving a motor vehicle or operating machinery
    •
    drowsiness may occur

    Stop use and ask a doctor if

    •
    nervousness, dizziness, or sleeplessness occur
    •
    pain or nasal congestion gets worse or lasts more than 7 days
    •
    new symptoms occur
    •
    fever gets worse or lasts more than 3 days
    •
    redness or swelling is present

    These could be signs of a serious condition.

    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. (1-800-222-1222) 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 take more than directed (see Liver warning)

    adults and children 12 years and over
    •
    take 2 caplets every 4-6 hours
    •
    swallow whole – do not crush, chew or dissolve
    •
    do not take more than 10 caplets in 24 hours

    children under 12 years

    ask a doctor
  • Inactive ingredients

    acesulfame potassium, carnauba wax, flavor, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    See New Warnings and Directions

    Compare to Tylenol® Allergy Multi-Symptom active ingredients

    FOR ADULTS

    allergy

    Multi-Symptom

    Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl

    PAIN RELIEVER, NASAL DECONGESTANT, ANTIHISTAMINE

    Headache

    Nasal Congestion

    Sinus Pressure

    Runny Nose/Sneezing

    Itchy, Watery Eyes

    24 Cool Ice® CAPLETS

    Perrigo Allergy 1.jpg
    Perrigo Allergy 2.jpg
  • INGREDIENTS AND APPEARANCE
    ALLERGY 
    acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0113-2476
    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
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    ColorWHITE (off white) Scoreno score
    ShapeCAPSULESize19mm
    FlavorVANILLA (Vanilla-menthol) Imprint Code L476
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0113-2476-6212 in 1 CARTON03/20/2014
    12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/20/2014
    Labeler - L. Perrigo Company (006013346)
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