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acetaminophen 325 mg / phenylephrine hydrochloride 5 mg oral tablet [wal-phed pe sinus headache] - 44 502 oval orange

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Active Ingredients (in Each Caplet)


Acetaminophen 325 mgPhenylephrine HCl 5 mg

Purpose


Pain reliever/fever reducerNasal decongestant

Uses

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

Warnings


Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg) 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

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

Ask a doctor before use if you have

  • diabetes
  • liver disease
  • heart disease
  • thyroid disease
  • high blood pressure
  • difficulty in urination due to enlargement of the 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • do not use more than directed
  • adults and children 12 years and over
    • take 2 caplets every 4 hours
    • do not take more than 10 caplets in 24 hours
  • children under 12 years: ask a doctor

Other Information

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive Ingredients


corn starch, croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, povidone, silica gel, stearic acid

Questions Or Comments?


1-888-287-1915

Principal Display Panel


NDC 49035-502-08

equateâ„¢

Compare toSudafed PE®Pressure + PainActiveIngredients*

Pressure & PainSuphedrine PEAcetaminophen and Phenylephrine HClPain Reliever, Fever Reducer, Nasal Decongestant

Non-Drowsy

Relieves:• Sinus pressure & congestion• Sinus headache & pain

Maximum Strength

24 CAPLETS

Actual Size

TAMPER EVIDENT: DO NOT USE IFPACKAGE IS OPENED OR IF BLISTERUNIT IS TORN, BROKEN OR SHOWSANY SIGNS OF TAMPERING

DISTRIBUTED BY: Wal-Mart Stores, Inc.,Bentonville, AR 72716 

*This product is not manufactured ordistributed by McNeil Consumer Healthcare,owner of the registered trademark SudafedPE® Pressure + Pain.50844                   REV0915B50208

Satisfaction guaranteed -Or we'll replace it or giveyou your money back.For questions or commentsor to report an undesiredreaction or side effect,please call 1-888-287-1915.
Equate 44-502

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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