Label: LEADER ALLERGY MULTI SYMPTOM- acetaminophen, chlorpheniramine maleate and phenylephrine hydrochloride tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/14

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

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  • Purpose

    Pain reliever

    Antihistamine

    Nasal decongestant

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  • Uses

    temporarily 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
    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
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  • Warnings

    Liver warning: This product contains acetaminophen. 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

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    skin reddening
    blisters
    rash

    If a skin reaction occurs, stop use and seek medical help right away.

    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
    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
    taking sedatives or tranquilizers

    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

    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.

    Overdose warning: 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.

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  • Directions

    do not take more than directed (see overdose 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

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  • Inactive ingredients

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

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  • Questions or comments?

    1-800-719-9260

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  • Principal Display Panel

    SEE NEW WARNINGS

    Allergy Multi-Symptom

    Pain Reliever – Acetaminophen

    Antihistamine – Chlorpheniramine Maleate

    Nasal Decongestant – Phenylephrine HCl

    For Adults

    Headache – Sinus Pressure

    Nasal Congestion

    Runny Nose / Sneezing

    Itchy, Watery Eyes

    Actual Size

    Instant Cooling Sensation

    Cool Ice®

    24 CAPLETS

    May Cause Drowsiness

    Leader Allergy Multi-Symptom Image 1
    Leader Allergy Multi-Symptom Image 2
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  • INGREDIENTS AND APPEARANCE
    LEADER ALLERGY MULTI SYMPTOM 
    acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:37205-940
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
    CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE 2 mg
    PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    ACESULFAME POTASSIUM  
    CARNAUBA WAX  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOLS  
    POLYVINYL ALCOHOL  
    POVIDONES  
    STEARIC ACID  
    TALC  
    TITANIUM DIOXIDE  
    FERRIC OXIDE YELLOW  
    Product Characteristics
    Color WHITE (off white) Score no score
    Shape CAPSULE Size 19mm
    Flavor VANILLA (Vanilla-menthol) Imprint Code L476
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37205-940-62 12 in 1 CARTON
    1 2 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 01/18/2006
    Labeler - Cardinal Health (097537435)
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