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Acetaminophen Phenylephrine Hcl Chlorpheniramine Maleate

OTC Oral RxCUI 2599517
Contents

Overview

Active ingredient
Acetaminophen, Phenylephrine Hydrochloride, Chlorpheniramine Maleate
Route
Oral
Label date
2024-10-17

Indications and usage

Uses Temporarily relieves common cold and flu symptoms:

  • sore throat
  • headache
  • minor aches and pains
  • fever
  • stuffy/runny nose and sneezing

Purpose

Pain reliever/fever reducer Nasal decongestant Antihistamine

Dosage and administration

Directions

  • Do not take more than recommended dose Adults and children 12 years of age and over: take 1 capsule with water every 4 hours.
  • Do not exceed 6 capsules in 24 hours Children under 12 years of age: do not use

Warnings

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

  • More than 4,000 mg 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. Allergy alert: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms can include
  • skin reddening
  • blisters
  • rash
  • hives
  • facial swelling
  • asthma (wheezing)
  • shock. If a skin or any allergic reaction occurs, stop use and seek medical attention right away. Sore throat warning: Severe or persistent sore throat lasting more than 2 days or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a Doctor promptly.

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. If you are now taking a prescription Monoamine Oxidase Inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or if you have taken these products 2 weeks previously. If you do not know if your prescription drug contains an MAOI, ask a Doctor before taking this product

Ask a doctor before use if

Ask a Doctor before use if you have

  • Liver disease
  • Heart disease
  • High blood pressure
  • Thyroid disease
  • Diabetes
  • Glaucoma
  • Breathing problem due to any given cause (asthma, chronic bronchitis or emphysema)
  • Trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if

Ask a Doctor before use if you are

  • Taking sedatives or tranquilizers
  • Taking the blood thinning drug warfarin

When using this product

this product

  • Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a Doctor.
  • Do not mix with alcohol, sedatives and tranquilizers as they may increase drowsiness
  • Driving a motor vehicle or operating machinery could be affected
  • Excitability may occur especially in children(12-18 y)
  • if symptoms do not improve within 7 days or are accompanied by fever, consult a Doctor

Stop use and ask a doctor if

and ask a Doctor if

  • Pain, or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults)
  • Fever gets worse or last more than 3 days
  • Redness or swelling is present
  • New symptoms occur

Active ingredient (label)

s Acetaminophen 325 mg Phenylephrine HCl 10 mg Chlorpheniramine Maleate 4 mg

Inactive ingredients

s Colloidal Silcon Dioxide, D&C Red No. 28, D&C Red No. 33, D&C Yellow No. 10, FD&C Blue No. 1, Gelatin, Lactose Monohdyrate, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Shellac, Synthetic Iron Oxide, Titanium Dioxide

Keep out of reach of children

of children If pregnant or breast-feeding, ask a health professional before use . As with all medical products keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.