Pain And Sinus Tablet
FDA Label NDC 73598-1192

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Jhk Inc Dba American Safety & First Aid for the product Pain And Sinus (NDC 73598-1192). 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 other, otc - purpose, use, liver warning, do not use, otc - ask doctor, otc - ask doctor/pharmacist, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

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.

Otc - Purpose

Active ingredient (In Each Tablet)Purpose
Acetaminophen 500 mgpain reliever/fever reducer
Phenylephrine 5 mgnasal decongestant

Use

temporarily relieves:

  • headache
  • sinus pain
  • nasal and sinus congestion
  • minor aches and pains
  • fever

Liver Warning

This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 8 tablets or 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen (prescription or nonprescription)
  • 3 or more alcoholic drinks every day while using this product

Do Not Use

  • 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 two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before using this product
  • for more than 3 days for fever unless directed by a doctor
  • with any other product containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a pharmacist
  • for more than 10 days for pain unless directed by a doctor

Otc - Ask Doctor

Ask a doctor before use if you have liver disease, heart disease, high blood pressure, thyroid disease, diabetes or difficulty in urination due to enlargement of the prostate gland.

Otc - Ask Doctor/Pharmacist

Ask a doctor before use if you are taking the blood thinning drug warfarin.

Stop Use And Ask A Doctor If

  • nervousness, dizziness, or sleeplessness occur
  • pain or nasal congestion gets worse or lasts more than 7 days
  • pain gets worse or lasts more than 10 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.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdose Warning

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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

Adults and children 12 years of age and older:

  • Take 2 tablets every 6 hours
  • do not exceed 8 tablets in 24 hours
  • Children under 12 years of age: Ask a doctor

Other Information

  • store at room temperature between 20-25 °C (68-77° F)
  • do not use if packet is opened or torn

Inactive Ingredients

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

Questions?

1-866-651-3660 Monday-Friday 8:00am-5:00pm EST

Principal Display Panel - 100 Tablet Packet Box

Product #1192

Pain & Sinus
Reliever

Active ingredient:
Acetaminophen
Phenylephrine

Pain Reliever/Nasal Decongestant

  • Formulated for relief from sinus pressure
    and nasal congestion
  • Aspirin free non-drowsy formula
  • These quality comfort tablets are formulated and packaged for use in the workplace
    and meet ANSI Z308.1-2021 standards.
    They are sealed in tamper evident packets for safety and convenience.

    100 Tablets • 2 Tablets Per Packet

    Principal Display Panel (100 Tablet Packet Box)

    Principal Display Panel (100 Tablet Packet Box)

* Please review the disclaimer below.