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Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Bitartrate, Doxylamine Succinate

OTC Oral RxCUI 1086997
Contents

Overview

Route
Oral
Label date
2025-12-04

Indications and usage

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

Dosage and administration

Directions Directions do not take more than the recommended dose · do not take the Day and Night products at the same time; wait 4 hours after the last Night dose before starting Day product. · adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 6 capsules in 12 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 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 tablet) Acetaminophen 325 mg…………….……….Pain reliever/fever reducer Dextromethorphan hydrobromide 10 mg…………..Cough suppressant Phenylephrine hydrochloride 5 mg…………………Nasal decongestant

Inactive ingredients

FD&C yellow #6, ferric oxide, gelatin, glycerin, polyethylene glycol, potassium aluminum silicate, povidone, propylene glycol, purified water, shellac, sodium hydroxide, 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.