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Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride

Dosage form
CAPSULE, LIQUID FILLED
Labeler
Prodose, Inc.
Label updated
2026-07-24
Retrieved
2026-09-07
Active ingredients
ACETAMINOPHEN · DEXTROMETHORPHAN HYDROBROMIDE · PHENYLEPHRINE HYDROCHLORIDE
View original label and images on DailyMed ↗
Active ingredient (in each Softgel)

Acetaminophen USP 325 mg

Dextromethorphan HBr USP 10 mg

Phenylephrine HCl USP 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

Temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever
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 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, or emphysema
Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

When using this product,

do not use more than directed.

Stop use and ask a doctor if
  • you get nervous, dizzy or sleepless
  • pain, nasal congestion 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.
If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach 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.

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

Other information
  • stored at 15° - 25°C (59° - 77°F)
Inactive ingredients

D&C yellow no. 10, gelatin, glycerin, polyethylene glycol 400, povidone k 30, propylene glycol, purified water, sorbitol sorbitan solution

포장 표시

label

[Image in the official label — see DailyMed source]

DailyMed Set ID: 3afc88c7-388a-dbd9-e063-6294a90a4faf · Version 4
NDC: 68210-5053