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leader sinus congestion and pain

Cardinal Health

Cardinal Health Sinus Congestion & Pain Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each caplet)

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Nasal decongestant

leader sinus congestion and pain Uses

  • •temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
  • •headache
  • •sinus congestion and pressure
  • •nasal congestion
  • •minor aches and pains
  • •helps decongest sinus openings and passages
  • •promotes sinus drainage
  • •helps clear nasal passages
  • •temporarily reduces fever

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

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

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

When using this product

do not exceed recommended dosage

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.

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 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

    leader sinus congestion and pain Other information

    • •store at 20-25°C (68-77°F)
    • •do not use if blister unit is broken or torn

    Inactive ingredients

    acesulfame potassium, carnauba wax, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavor, lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

    Questions or comments?

    1-800-719-9260

    Principal Display Panel

    Compare to Tylenol® Sinus Congestion & Pain active ingredients

    For Adults

    Sinus Congestion & Pain

    Pain Reliever/Fever Reducer – Acetaminophen

    Nasal Decongestant – Phenylephrine HCl

    Daytime Non-Drowsy

    Sinus Headache

    Sinus Pressure

    Nasal Congestion

    Actual Size

    Instant Cooling Sensation

    Cool Ice®

    24 CAPLETS

    leader sinus congestion and pain

    Acetaminophen, Phenylephrine HCl TABLET, FILM COATED

    Product Information

    Product Type Human otc drug label Item Code (Source) NDC:37205-571
    Route of Administration ORAL DEA Schedule

    Active Ingredient/Active Moiety

    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN ACETAMINOPHEN 325 mg
    Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

    Inactive Ingredients

    Ingredient Name Strength
    ACESULFAME POTASSIUM
    carnauba wax
    CROSPOVIDONE
    cellulose, microcrystalline
    POLYETHYLENE GLYCOLS
    POLYVINYL ALCOHOL
    POVIDONES
    STEARIC ACID
    talc
    titanium dioxide

    Product Characteristics

    Color Size Imprint Code Shape
    GREEN 16 mm L272 OVAL

    Packaging

    # Item Code Package Description Marketing Start Date Marketing End Date
    1 2 in 1 BLISTER PACK
    2 NDC:37205-571-62 12 in 1 CARTON

    Marketing Information

    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    part part341 2007-01-12


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    Be sure to consult your doctor before taking any medication!
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