Label: ALLERGY- acetaminophen, chlorpheniramine maleate, phenylephrine hcl 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 December 11, 2019

If you are a consumer or patient please visit this version.

  • 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)