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sinus congestion and pain (acetaminophen 325 mg phenylephrine hydrochloride 5 mg) Dailymed

  1. Human OTC
  2. Archived
  3. H E B

Generic: acetaminophen, phenylephrine hcl

sinus congestion and pain tablet, film coated - (acetaminophen 325 mg phenylephrine hydrochloride 5 mg) image

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    COLOR: green

  1. FDA Adverse Reactions

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Active Ingredients (in Each Caplet)


Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Purpose


Pain reliever

Nasal decongestant

Uses

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

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

    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

    SINUS CONGESTION & PAIN

    Daytime Non-Drowsy

    Acetaminophen – Phenylephrine Hydrochloride

    Pain Reliever – Nasal Decongestant

    Headache Pain

    Sinus Pressure

    Nasal Congestion

    Instant Cooling Sensation

    Cool Ice® Caps

    ACTUAL SIZE

    See New Warnings and Directions

    GLUTEN FREE

    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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