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Topcare Sinus Congestion and Pain (acetaminophen 325 mg phenylephrine hydrochloride 5 mg) Dailymed



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Active Ingredient (in Each Caplet) - Nighttime


Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Phenylephrine HCl 5 mg

Purpose - Nighttime


Pain reliever

Antihistamine

Nasal decongestant

Uses - Nighttime

  • •for the temporary relief of:
  • •headache
  • •sinus congestion and pressure
  • •nasal congestion
  • •runny nose and sneezing
  • •minor aches and pains
  • •reduces swelling of nasal passages
  • •helps decongest sinus openings and passages

Warnings - Nighttime


Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
  • •more than 12 caplets in 24 hours, which is the maximum daily amount
  • •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.
  • •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 sedatives or tranquilizers
  • •taking the blood thinning drug warfarin

When using this product

  • •do not use more than directed
  • •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

  • •you get nervous, dizzy or sleepless
  • •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 - Nighttime

  • •do not take more than directed (see Liver warning)
  • •do not take the Day and Night caplets at the same time
  • •do not take more than a total of 12 caplets in 24 hours
take 2 caplets every 4-6 hours
  • swallow whole – do not crush, chew or dissolvedo not use this adult product in children under 12 years of age

    adults and children 12 years and over
    • •

    children under 12 years
    •

    Inactive Ingredients - Nighttime


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

    Questions Or Comments? - Nighttime


    1-888-423-0139

    Active Ingredient (in Each Caplet) - Daytime


    Acetaminophen 325 mg

    Phenylephrine HCl 5 mg

    Purpose - Daytime


    Pain reliever

    Nasal decongestant

    Uses - Daytime

    • •for the temporary relief of:
    • •headache
    • •sinus congestion and pressure
    • •nasal congestion
    • •minor aches and pains
    • •helps decongest sinus openings and passages
    • •promotes sinus drainage
    • •helps clear nasal passages

    Warnings - Daytime


    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
    • •more than 12 caplets in 24 hours, which is the maximum daily amount
    • •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.

    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 use more than directed

    Stop use and ask a doctor if

    • •you get nervous, dizzy or sleepless
    • •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 - Daytime

    • •do not take more than directed (see Liver warning)
    • •do not take the Day and Night caplets at the same time
    • •do not take more than a total of 12 caplets in 24 hours
    take 2 caplets every 4 hours
  • swallow whole – do not crush, chew or dissolve

    adults and children 12 years and over
    • •

    children under 12 years

    do not use this adult product in children

    under 12 years of age

    Inactive Ingredients - Daytime


    acesulfame potassium, carnauba wax, crospovidone, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, flavor, lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, starch, stearic acid, talc, titanium dioxide

    Questions Or Comments? - Daytime


    1-888-423-0139

    Principal Display Panel


    See New Warnings Information

    Daytime & Nighttime Convenience Pack

    Sinus

    Congestion & Pain

    Pain Reliever/Nasal Decongestant/*Antihistamine

    Day

    Non-Drowsy

    Contains 2 Medicines:

    Headache/Acetaminophen

    Sinus Pressure/Nasal Congestion – Phenylephrine HCl

    Night

    *Antihistamine in Nighttime Only

    Contains 3 Medicines:

    Headache/Acetaminophen

    Sinus Pressure/Nasal Congestion – Phenylephrine HCl

    Runny Nose – Chlorpheniramine Maleate

    Instant Cooling Sensation

    Cool Ice®

    Actual Size

    Compare to Tylenol® Sinus Congestion & Pain Day & Night active ingredients
    Sinus Congestion and Pain Carton
    Sinus Congestion and Pain Carton

    DISCLAIMER:

    "This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

    "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

    "This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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