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Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl, and Triprolidine Hcl

OTC Oral RxCUI 1116572
Contents

Overview

Route
Oral
Label date
2026-03-11

Indications and usage

Uses Day:

  • temporarily relieves these common cold and flu symptoms:
  • cough
  • nasal congestion
  • minor aches and pains
  • sore throat
  • headache
  • stuffy nose
  • sinus congestion and pressure
  • temporarily reduces fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive Night:
  • temporarily relieves these common cold and flu symptoms:
  • cough
  • minor aches and pains
  • sore throat
  • headache
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes due to hay fever
  • temporarily reduces fever
  • controls cough to help you get to sleep

Purpose

Day: Acetaminophen 650mg.................................Pain reliever/fever reducer Dextromethorphan HBr 20 mg.....................................Cough suppressant Guaifenesin 400 mg..............................................................................Expectorant Phenylephrine HCl 10 mg..........................................................Nasal decongestant Night: Acetaminophen 650 mg............................ ...Pain reliever/fever reducer Dextromethorphan HBr 20 mg....................................Cough suppressant Triprolidine HCl 2.5 mg................................................Antihistamine

Dosage and administration

Directions Day: do not take more than directed (see Overdose warning)

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours
  • children under 12 years of age: do not use Night:
  • do not take more than directed (see Overdose warning)
  • do not take more than 4 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours
  • children under 12 years of age: do not use

Warnings

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

  • more than 6 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product Allergy 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. 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
  • 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. Ask a doctor before use if you have
  • liver disease
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not use more than directed Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. Night: Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
  • more than 4 doses (80 mL) in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product Allergy 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. 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
  • 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. Ask a doctor before use if you have
  • liver disease
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers When using this product
  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if
  • pain or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

Active ingredient (label)

s (in each 20 mL) Day: Acetaminophen 650mg Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg Night: Acetaminophen 650 mg Dextromethorphan HBr 20 mg Triprolidine HCl 2.5 mg

Inactive ingredients

s Day: ammonium glycyrrhizate, anhydrous citric acid, D&C yellow no. 10, edetate disodium, FD&C blue no. 1, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum Night: ammonium glycyrrhizate, anhydrous citric acid, D&C yellow no. 10, edetate disodium, FD&C red no. 40, flavor, glycerin (soy), propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Keep out of reach 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 right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.