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

  1. Human OTC
  2. Archived
  3. L.N.K. International, Inc.

Generic: acetaminophen and phenylephrine hcl

Sinus Congestion and Pain tablet, film coated - (acetaminophen 325 mg phenylephrine hydrochloride 5 mg) image

IMPRINT: 44 466     SHAPE: oval
    COLOR: green

  1. FDA Adverse Reactions

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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 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. Severe liver damage may occur if you take:
  • more than 4,000 mg in 24 hour, which is the maximum daily amount
  • 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:
  • bulers
  • rash
  • skin reddening

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


  • liver disease

  • difficulty in urination due to enlargement of the prostate gland

  • heart disease

  • diabetes

  • thyroid disease

  • high blood pressure

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

  • new symptoms occur

  • fever gets worse or lasts more than 3 days

  • redness or swelling is present

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 take more than directed

  • adults and children 12 years and over

    • take 2 caplets every 4 hours

    • swallow whole – do not crush, chew, or dissolve

    • 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 

  • see end flap for expiration date and lot number
  • store at 25ÂşC (77ÂşF); excursions permitted between 15°-30°C  (59°-86°F)

Inactive Ingredients


corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavor, magnesium stearate,  microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Questions Or Comments?


call 1-800-426-9391

Principal Display Panel


QUALITY PLUS

NDC 50844-466-02

*Compare to the active ingredients in Tylenol® SINUS + HEADACHEDAYTIMENON-DROWSY SINUSCONGESTION & PAINAcetaminophen, Phenylephrine HCl

Pain reliever/Fever reducer, Nasal decongestant

For Relief of:Sinus Headache • Sinus Pressure • Nasal Congestion

12 Caplets

Pseudoephedrine Free

Actual Size

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

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® SINUS + HEADACHE.50844       REV0316E46602

Distributed by LNK INTERNATIONAL, INC. 60 Arkay Drive, Hauppauge, NY 11788 USA Quality Plus 44-466C

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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