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Major Pharmaceuticals Acetaminophen Congestion and Pain Drug Facts


Active ingredients (in each caplet)

Acetaminophen 325 mg

Phenylephrine HCl 5 mg


Purpose

Pain reliever/fever reducer

Nasal decongestant


Uses

  • •temporarily relieves these symptoms associated with hay fever or other upper 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

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
  • •3 or more alcoholic drinks every day while using this product

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

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
  • •fever gets worse or lasts more than 3 days
  • •redness or swelling is present
  • •new symptoms occurThese could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.


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.


Directions

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 yearsask a doctor
  • •do not take more than directed (see overdose warning)

Inactive ingredients

acesulfame potassium, carnauba wax, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavor, lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide