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Sinus Headache PE (acetaminophen 325 mg phenylephrine hydrochloride 5 mg) Dailymed

  1. Human OTC
  2. Archived
    • May Be Discontinued
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  3. SUPERVALU INC.

Generic: acetaminophen and phenylephrine hcl

Sinus Headache PE tablet - (acetaminophen 325 mg phenylephrine hydrochloride 5 mg) image
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IMPRINT: 44 502     SHAPE: capsule
    COLOR: orange

All Imprints

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

  1. FDA Adverse Reactions

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Active Ingredients (in Each Caplet)


Acetaminophen 325 mgPhenylephrine HCl 5 mg

Purpose


Pain relieverNasal decongestant 

Uses

  • temporarily relieves headache, minor aches and pains
  • temporarily relieves nasal congestion 

Warnings


 Liver warning: This product containsa 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 an 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


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.


Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. 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 use more than directed (see overdose warning)
  • adults and children 12 ears and over
    • take 2 caplets every 4 hours
    • do not take more than 12 caplets in 24 hours
  • children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage. 

Other Information

  • 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?


1-877-932-7948

Principal Display Panel


equaline

compare to the active ingredients in Sudafed PE® Pressure + Pain*

NDC 41163-502-08

non-drowsy, maximum strength sinus headache PE acetaminophen and phenylephrine HClpain reliever, nasal decongestant

• sinus pain & headache• sinus pressure• nasal & sinus congestion

pseudoephedrine free

24 caplets

DOES NOT CONTAIN GLUTEN

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed PE® Pressure + Pain.50844    REV0410B50208

DISTRIBUTED BY SUPERVALU INC.EDEN PRARITE, MN 55344 USA

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING equaline 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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