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First Aid Direct Headache and Congestion Sinus Relief



OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each tablet)

Acetaminophen 500 mg

Phenylephrine HCl 5 mg


OTC - PURPOSE SECTION

Purpose

Pain reliever/fever reducer

Nasal decongestant


INDICATIONS & USAGE SECTION

Uses

temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold: 

  • sinus congestion and pressure
  • headache
  • minor aches and pains
  • nasal congestion
  • promotes sinus drainage
  • temporarily reduces fever

WARNINGS SECTION

Warnings

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

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product

OTC - DO NOT USE SECTION

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.
  • 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 are allergic to acetaminophen or any of the inactive ingredients in this product.

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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


OTC - STOP USE SECTION

Stop use and ask doctor if

These could be signs of a serious condition. 

  • nervousness, dizziness, or sleplessness 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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.


DOSAGE & ADMINISTRATION SECTION

Directions

  • adults and children 12 years and older: • take 2 tablets every 6 hours • do not take more than 8 tablets in 24 hours
  • children under 12 years of age: ask a doctor

OTHER SAFETY INFORMATION

Other information

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

INACTIVE INGREDIENT SECTION

Inactive ingredients

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


OTC - QUESTIONS SECTION

Questions?

Call 1-800-327-2704 M-F 8AM-5PM