Sinu-phen Plus Tablet
FDA Label NDC 84269-2546

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wildman Business Group for the product Sinu-phen Plus (NDC 84269-2546). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, indications & usage, warnings, other, do not use, ask doctor, ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Active ingredients (in each tablet)

Acetaminophen 500mg

Phenylephrine HCl 5mg

Purpose

Purpose

Pain reliever/fever reducer

Nasal decongestant

Indications & Usage

Uses

temporarily relieves these common cold/flu symptoms:

  • nasal congestion
  • headache
  • minor aches and pains
  • stuffy nose
  • sinus congestion and pressure temporarily reduces fever

Warnings

Warnings

Other

Liver warning: This product contains acetaminophen. 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
    • blisters
    • rash

      • If a skin reaction occurs, stop use and seek medical help right away.

Do Not Use

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.
  • for more than 10 days unless directed by a doctor

Ask Doctor

Ask a doctor before use if you have

  • liver disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • heart disease
  • trouble urinating due to an enlarged prostate gland

Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin

When Using

When using this product do not exceed recommended dosage.

Stop Use

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 appear

    • These could be signs of a serious condition.

Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Keep Out Of Reach Of Children

Keep out of reach of children.

Overdose warning:

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.

Dosage & Administration

Directions

  • do not use more than directed

    • Adults and children: (12 years and over) Take 2 tablets every 6 hours. Do not take more than 8 tablets in 24 hours.

    Children under 12 years: Ask a doctor

Other Safety Information

Other information

  • store at room temperature 59°-86°F (15°-30°C)
  • tamper evident sealed packets
  • do not use any opened or torn packets
  • avoid excessive heat and humidity

Inactive Ingredient

Inactive ingredients

corn starch, crospovidone, hypromelloses, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid.

Questions

Questions or comments? (888) 602-0288

Principal Display Panel – 250 Tablet Box Label

Sinu-Phen Plus

Sinus Pain & Pressure

Acetaminophen 500 mg

Phenylephrine HCl 5 mg

Pull to Open

Fast Relief of:

  • Fever
  • Nasal Congestion
  • Body Aches
  • Sinus Pain

    • The Provision

    First Aid

    Line™

    BY WILDMAN

    250 tablets

    2 Per Packet

    Figure (Sin0e 0000 01)

    Figure (Sin0e 0000 01)

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