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Acetaminophen,Dextromethrophan Hbr,Doxylamine Succinate

OTC Oral RxCUI 1094549
Contents

Overview

Active ingredient
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
Route
Oral
Label date
2026-05-10

Indications and usage

Uses Temporarily relieves common cold/flu symptoms:

Purpose

  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches & pain
  • fever
  • runny nose & sneezing

Dosage and administration

Directions

  • take only as directed (see Warning)
  • do not exceed 4 doses per 24 hours Adults & Children 12 years & over: 2 soft gels with water every 6 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 4 doses in 24 hours, which is the maximum daily amount for this product
  • 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, lasts for more than 2 days, occurs with or is 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
  • to make a child sleep

Ask a doctor before use if

Ask a doctor before use if you have

  • liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
  • trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product

this product do not use more than directed .

  • excitability may occur, especially in children,
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • When using other Daytime or Nighttime products, carefully read each label to ensure correct dosing.

Stop use and ask a doctor if

and ask a doctor if

  • pain 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 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)

Drug Facts Active ingredients (in each Softgel) Acetaminophen 325 mg............. Pain reliever/Fever reducer Dextromethorphan HBr 15 mg..... Cough suppressant Doxylamine succinate 6.25 mg ..... Antihistamine

Inactive ingredients

s D&C Yellow # 10, FD&C Blue # 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, Sorbitol sorbitan solution, Titanium dioxide.

Keep out of reach of children

of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for aduits as well as for children, even if you do not notice any signs or symptoms.