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Acetaminophen, Phenylephrine Hydrochloride, and Doxylamine Succinate

OTC RxCUI 1043400
Contents

Overview

Label date
2026-08-19

Indications and usage

Uses

  • temporarily relieves common cold/flu symptoms:
  • nasal congestion
  • cough due to minor throat & bronchial irritation
  • minor aches & pains
  • headache
  • fever
  • sore throat

Uses temporarily relieves common cold/flu symptoms:

  • cough due to minor throat & bronchial irritation
  • minor aches & pains
  • headache
  • fever
  • sore throat
  • runny nose & sneezing

Purpose

Pain reliever/Fever reducer Cough suppressant Nasal decongestant

Pain reliever/Fever reducer Cough suppressant Antihistamine

Dosage and administration

Directions

  • take only as directed
  • Only use the dose cup provided
  • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 4 hours Children 6 to under 12 yrs 15 mL every 4 hours children 4 to under 12 yrs ask a doctor children under 4 yrs do not use

Directions

  • take only as directed
  • Only use the dose cup provided
  • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 4 hours children 4 to under 12 yrs ask a doctor children under 4 yrs do not use

Warnings

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

  • adult takes more than 4 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product
  • child takes more than 4 doses (15 mL each) in 24 hours, which is the maximum daily amount for this product
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day 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
  • High blood pressure
  • Thyroid disease
  • Diabetes
  • Trouble urinating due to enlarged prostate gland
  • Cough that occurs with too much phlegm (mucus)
  • Persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • A sodium-restricted diet 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
  • you get nervous, dizzy or sleepless
  • pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adult)
  • 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. 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.

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

  • more than 4 doses in 24 hours, which is the maximum daily amount for this product
  • taken with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day 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 enlarged prostate gland
  • Cough that occurs with too much phlegm (mucus)
  • A breathing problem or chronic cough such as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if you are
  • Taking sedatives or tranquilizers
  • Taking the blood thinning drug warfarin When using this product
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives & tranquilizers may increase drowsiness 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. 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.

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.
  • 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 enlarged prostate gland
  • Cough that occurs with too much phlegm (mucus)
  • A breathing problem or chronic cough such as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if you are
  • Taking sedatives or tranquilizers
  • Taking the blood thinning drug warfarin

Ask a doctor before use if

Ask a doctor before use if you have

  • Liver disease
  • Heart disease
  • High blood pressure
  • Thyroid disease
  • Diabetes
  • Trouble urinating due to enlarged prostate gland
  • Cough that occurs with too much phlegm (mucus)
  • Persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • A sodium-restricted diet

Ask a doctor before use if you have

  • Liver disease
  • glaucoma
  • Trouble urinating due to enlarged prostate gland
  • Cough that occurs with too much phlegm (mucus)
  • A breathing problem or chronic cough such as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if you are
  • Taking sedatives or tranquilizers
  • Taking the blood thinning drug warfarin

Ask a doctor or pharmacist before use if

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Ask a doctor or pharmacist before use if you are

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

When using this product

this product, do not use more than directed.

this product

  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives & tranquilizers may increase drowsiness

Stop use and ask a doctor if

and ask a doctor if

  • you get nervous, dizzy or sleepless
  • pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adult)
  • 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.

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.

Pregnancy or breast-feeding

If pregnant or breast-feeding, ask a health professional before use.

If pregnant or breast-feeding, ask a health professional before use.

Active ingredient (label)

s (in each 15 mL) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg Purpose Pain reliever/Fever reducer Cough suppressant Nasal decongestant

s (in each 30 mL) Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg Purpose Pain reliever/Fever reducer Cough suppressant Antihistamine

Inactive ingredients

s Anhydrous citric acid, disodium edetate, FD&C Yellow No. 6, flavor, glycerin, menthol, potassium citrate, propyl gallate, purified water, sodium benzoate, sodium chloride, sorbitol, sucralose, xanthan gum

s Citric acid, D&C Yellow No. 10, disodium edetate, FD&C Green No.3, FD&C Yellow no 6, flavor, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

Storage and handling

Other information each 15 mL contains :

  • sodium 42 mg
  • store at room temperature
  • Do not refrigerate.

Other information

  • each 30 mL contains: sodium 16 mg
  • Store at room temperature
  • Do not refrigerate

Keep out of reach of children

of children. 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.

of children. 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.