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Acetaminophen, Dextromethorphan Hbr

OTC Oral RxCUI 1867684
Contents

Overview

Active ingredient
Acetaminophen, Dextromethorphan Hydrobromide
Route
Oral
Label date
2026-08-06

Indications and usage

Uses Temporarily relieves common cold and flu symptoms:

  • Minor aches and pains
  • Headache
  • Sore throat
  • Fever
  • Cough due to minor throat and bronchial irritation

Purpose

Acetaminophen 325 mg ........................................ Pain reliever/fever reducer Dextromethorphan HBr 10 mg ......................... Cough suppressant

Dosage and administration

Directions Take only as directed-see OVERDOSE WARNING. Do not exceed 8 softgels per 24 hours. Adults & children 12 years and over Take 2 softgels with water every 4 hours Children 4 to under 12 years Ask a doctor Children under 4 years Do not use

Warnings

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. Liver warning This product contains acetaminophen. Severe liver damage may occur if you take:
  • More than 8 softgels in 24 hours, 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 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.

Ask a doctor before use if

Ask a doctor before use if you have:

  • liver disease
  • diabetes
  • heart disease
  • thyroid disease
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
  • 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

Ask a doctor before use 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 or pharmacist before use if you are

  • Taking the blood thinning drug warfarin.

When using this product

this product

  • Do not exceed recommended dosage.

Stop use and ask a doctor if

and ask a doctor if

  • Pain, cough, or nasal congestion gets worse or lasts more than 7 days.
  • New symptoms occur.
  • Nervousness, dizziness, or sleeplessness occur.
  • Fever gets worse or lasts more than 3 days.
  • Redness or swelling is present.
  • Cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

Overdosage

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Pregnancy or breast-feeding

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

Active ingredient (label)

s (in each softgel) Acetaminophen 325 mg ........................................ Pain reliever/fever reducer Dextromethorphan HBr 10 mg ......................... Cough suppressant

Inactive ingredients

s Polyethylene Glycol-400, Propylene Glycol, Povidone (PVPK-30), FD & C Red No. 40, FD & C Yellow No. 6, Purified Water, Gelatin, Glycerin, Sorbitol Sorbitan Solution.

Keep out of reach of children

of children