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Acetaminophen, Dextromethorphan HBr ,Guaifenesin

Dosage form
CAPSULE, LIQUID FILLED
Labeler
Softgel Healthcare Pvt Ltd
Label updated
2026-04-27
Retrieved
2026-09-07
Active ingredients
ACETAMINOPHEN · DEXTROMETHORPHAN HYDROBROMIDE · GUAIFENESIN
View original label and images on DailyMed ↗
Active ingredients (in each Softgel)

Acetaminophen USP 325 mg

Dextromethorphan HBr USP 10 mg

Guaifenesin USP 200 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Uses

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat & bronchial irritation
  • minor aches & pains
  • headache
  • fever
  • sore throat
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passage ways of bothersome mucus and make coughs more productive.
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, chronic bronchitis, 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, cough get worse or last 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

  • store at no greater than 25°C
Inactive ingredients

FD&C blue no.1, FD&C red no. 40, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan solution

bulk-label

[Image in the official label — see DailyMed source]

DailyMed Set ID: 353ef34f-760d-ae92-e063-6294a90a5b4a · Version 5
NDC: 35916-0184