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Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate

OTC Oral RxCUI 1426334
Contents

Overview

Active ingredient
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
Route
Oral
Label date
2026-01-27

Indications and usage

Uses

  • temporarily relieves these symptoms due to a cold or flu :
  • minor aches and pains
  • headache
  • cough
  • sore throat
  • nasal and sinus congestion
  • temporarily reduces fever

Purpose

s Pain reliever/fever reducer Cough suppressant Antihistamine

Dosage and administration

Directions

  • do not take more than the recommended dose
  • adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor.
  • children under 12 years: do not use

Warnings

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:
  • skin reddening
  • blisters
  • rash
  • hives
  • facial swelling
  • asthma (wheezing)
  • shock If a skin or general allergic 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.
  • if you have ever had an allergic reaction to this product or any of its ingredients
  • in children under 12 years of age

Ask a doctor before use if

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • cough that occurs with excessive phlegm (mucus)
  • difficulty in urination due to enlargement of the prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, 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 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
  • 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.
  • nervousness, dizziness, or sleeplessness occurs

Pregnancy or breast-feeding

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

Active ingredient (label)

s (in each capsule) Acetaminophen USP 325 mg Dextromethorphan HBr USP 10 mg Doxylamine Succinate USP 6.25 mg

Inactive ingredients

s D&C yellow no.10, FD&C blue no.1, gelatin, glycerin, mica, polyethylene glycol 400, povidone K 30, purified water, sorbitol sorbitan solution, titanium dioxide

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.