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Acetaminophen, Guaifenesin, Phenylephrine Hcl and Dextromethorphan Hbr

OTC Oral RxCUI 1656815
Contents

Overview

Active ingredient
Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide, Acetaminophen, Guaifenesin
Established class
Expectorant
Physiologic effect
Decreased Respiratory Secretion Viscosity; Increased Respiratory Secretions
Route
Oral
Label date
2026-01-28

Indications and usage

Uses temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation minor aches & pains headache fever sore throat reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passage ways of bothersome mucus and make coughs more productive.

Purpose

Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant

Dosage and administration

Directions take only as directed do not exceed 8 softgels per 24 hrs adults & children 12 years & over 2 softgels with water every 4 hours children 4 to under 12 years ask a doctor children under 4 years do not use

Warnings

Liver warning: This product contains acetaminophen.Severe liver damage may occur if you take more than 8 softgels in 24 hrs, which is the maximum daily amount for this product 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

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, chronic bronchitis, or emphysema

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 you get nervous, dizzy or sleepless pain, nasal congestion or cough get worse or last 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.

Active ingredient (label)

s (in each Softgel) Acetaminophen USP 325 mg Dextromethorphan HBr USP 10 mg Guaifenesin USP 200 mg Phenylephrine HCl USP 5 mg

Inactive ingredients

s FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan solution

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.