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Allergy

L. Perrigo Company

Perrigo Allergy Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each caplet)

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever

Antihistamine

Nasal decongestant

Allergy 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)
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

    adults and children 12 years and over

    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

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    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

    Allergy

    Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET

    Product Information

    Product Type Human otc drug label Item Code (Source) NDC:0113-2476
    Route of Administration ORAL DEA Schedule

    Active Ingredient/Active Moiety

    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN ACETAMINOPHEN 325 mg
    Chlorpheniramine Maleate CHLORPHENIRAMINE 2 mg
    Phenylephrine Hydrochloride PHENYLEPHRINE 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 Size Imprint Code Shape
    WHITE (off white) 19 mm L476 CAPSULE

    Packaging

    # Item Code Package Description Marketing Start Date Marketing End Date
    1 2 in 1 BLISTER PACK
    2 NDC:0113-2476-62 12 in 1 CARTON

    Marketing Information

    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    part part341 2014-03-20


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    Be sure to consult your doctor before taking any medication!
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