FDA Label for Pain And Sinus Reliever

View Indications, Usage & Precautions

Pain And Sinus Reliever Product Label

The following document was submitted to the FDA by the labeler of this product Jhk Dba American Safety & First Aid. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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 - 250 Tablet Packet Box



Product #1194

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.

    250 Tablets • 2 Tablets Per Packet


* Please review the disclaimer below.