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Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride

OTC Oral RxCUI 1193293
Contents

Overview

Active ingredient
Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hydrochloride
Route
Oral
Label date
2024-10-24

Indications and usage

Uses temporarily relieves

  • minor aches and pains
  • headaches
  • nasal congestion
  • sinus congestion & pressure
  • runny nose
  • sneezing

Purpose

s Pain reliever/fever reducer Antihistamine Nasal decongestant

Dosage and administration

Directions

  • Do not use more than directed (see overdose warning)
  • Adults and children 12 years of age and older: take 1 tablet every 4 hours Do not take more than 6 tablets in 24 hours
  • Children under 12 years of age: do not use because this product contains to much medication for children under this age.

Warnings

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

  • more than 6 tablets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product Alergy 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

Do not use

  • If you are allergic to acetaminophen
  • more than 10 days unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor
  • if you are taking a 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 contasins an MAOI, ask a doctor or pharmacist before taking this product.
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if

Ask adoctor before use if you have

  • liver disease
  • heart disease
  • glaucoma
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if

Ask a doctor or pharmacist before use if you

  • are taking the blood thinning drug warfarin
  • are taking sedatives or tranquilizers

When using this product

this product

  • do not use more than directed
  • excitability may occur, especially in children
  • may cause drowsiness
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

and ask a doctor if

  • redness or swelling is present
  • new symptoms occur
  • you get nervous, dizzy, or sleepless
  • pain or nasal congestion gets worse or lasts for more than 7 days
  • fever gets worse or lasts for more than 3 days

Active ingredient (label)

s (in each tablet) Acetaminophen 325 mg Chlorpheniramine maleate 4 mg Phenylepherine HCl 10 mg

Inactive ingredients

s Lactose monohydrate (derived from milk), Stearic acid, Povidone, Alcohol, Water purified, Hypromellose, Titanium dioxide, Triacetin, contains FDC Yellow No. 5 (tartrazine) as color additive

Keep out of reach of children

of children If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children . Overdose warning : Taking more than the recommended dose (overdose) may cause liver damage. 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.