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Aspirin, Chlorpheniramine Maleate, Phylephrine Bitartrate

OTC Oral RxCUI 1536840
Contents

Overview

Active ingredient
Phenylephrine Bitartrate, Aspirin, Chlorpheniramine Maleate
Established class
Nonsteroidal Anti-inflammatory Drug; Platelet Aggregation Inhibitor
Mechanism class
Cyclooxygenase Inhibitors
Physiologic effect
Decreased Prostaglandin Production; Decreased Platelet Aggregation
Chemical structure
Anti-Inflammatory Agents, Non-Steroidal
Route
Oral
Label date
2024-11-13

Indications and usage

Uses

  • temporarily relieves these symptoms due to the common cold
  • sneezing
  • nasal congestion
  • sore throat
  • headache
  • minor aches and pains
  • runny nose
  • sinus congestion and pressure
  • temporarily reduces fever

Purpose

(in each effervescent tablet) . . . . . . . . . . . Purpose Aspirin 325 mg (NSAID)*. . . . . . . . . . . . . . . . . . .Pain reliever/fever reducer Chlorpheniramine maleate 2 mg . . . . . . . . . . . . Antihistamine Phenylephrine Bitartrate 7.8 mg . . . . . . . . . . .Nasal decongestant *Nonsteroidal anti-inflammatory drug

Dosage and administration

Directions

  • do not use more than directed (see overdose warning)
  • adults and children 12 years and over: take 2 tablets completely dissolved in 4 oz of water every 4 hours
  • do not take more than 8 tablets in 24 hours
  • children under 12 years: ask a doctor

Warnings

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

Do not use

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • if you are allergic to aspirin
  • 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

Ask a doctor before use if Ask a doctor before use if

  • stomach bleeding warning applies to you
  • you have a history of stomach problems such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic

Ask a doctor before use if you have Ask a doctor before use if you have

  • asthma
  • glaucoma
  • diabetes
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • been placed on a sodium-restricted diet

Ask a doctor or pharmacist before use if

Ask a doctor or pharmacist before use if you are Ask a doctor or pharmacist before use if you are

  • you are taking sedatives or tranquilizers
  • presently taking a prescription drug
  • taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout or arthritis

When using this product

this product When using this product

  • do not exceed recommended dosage
  • you may get drowsy
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

and ask a doctor if Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
  • an allergic reaction occurs. Seek medical help right away
  • pain or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present
  • ringing in the ears or a loss of hearing occurs
  • nervousness, dizziness or sleeplessness occurs

Overdosage

In case of overdose In case of overdose, get medical help or contact a Poison Control Center right away.

Pregnancy or breast-feeding

If pregnant or breast-feeding If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Active ingredient (label)

s Active ingredients (in each effervescent tablet) . . . . . . . . . . .Purpose Aspirin 325 mg (NSAID)*. . . . . . . . . . . . . . . . . . .Pain reliever/fever reducer Chlorpheniramine maleate 2 mg . . . . . . . . . . . . Antihistamine Phenylephrine Bitartrate 7.8 mg . . . . . . . . . . .Nasal decongestant *Nonsteroidal anti-inflammatory drug

Inactive ingredients

s acesulfame potassium, aspartame, citric acid, docusate sodium, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate

Keep out of reach of children

of children. Keep out of reach of children.