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Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin ,Phenylephrine Hcl

OTC Oral RxCUI 1116572
Contents

Overview

Active ingredient
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
Established class
Expectorant
Physiologic effect
Decreased Respiratory Secretion Viscosity; Increased Respiratory Secretions
Route
Oral
Label date
2017-09-01

Indications and usage

Uses

  • temporarily relieves these common cold and flu symptoms:
  • nasal congestion
  • sinus congestion and pressure
  • cough due to minor throat and bronchial irritation
  • minor aches and pains
  • sore throat
  • headache
  • temporarily reduces fever
  • temporarily promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Purpose

Active ingredients (in each 20 mL) Purposes Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan HBr 20 mg Cough suppressant Guaifenesin 400 mg Expectorant Phenylephrine HCl 10 mg Nasal decongestant

Dosage and administration

Directions

  • 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
  • mL= milliliter
  • Adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 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 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.
  • for children under 12 years of age
  • 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 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 rash, or persistent headache. 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.

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.
  • for children under 12 years of age
  • 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

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • 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

Ask a doctor or pharmacist before use if

  • you are taking the blood thinning drug warfarin

When using this product

this product

  • do not use more than directed

Stop use and ask a doctor if

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 rash, or persistent headache. These could be signs of a serious condition.

Adverse reactions

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.

Pregnancy or breast-feeding

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

Active ingredient (label)

s (in each 20 mL) Purposes Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan HBr 20 mg Cough suppressant Guaifenesin 400 mg Expectorant Phenylephrine HCl 10 mg Nasal decongestant

Inactive ingredients

s anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavors, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Storage and handling

Other information

  • each 20 mL contains: sodium 8 mg
  • store at room temperature
  • do not refrigerate
  • dosing cup provided

Keep out of reach of children

of children.