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Guaifenesin and Pseudoephedrine Hcl

OTC Oral RxCUI 1244675
Contents

Overview

Active ingredient
Guaifenesin, Pseudoephedrine Hydrochloride
Established class
Expectorant
Physiologic effect
Decreased Respiratory Secretion Viscosity; Increased Respiratory Secretions
Route
Oral
Label date
2025-10-24

Indications and usage

Use(s)

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bother some mucus and make coughs more productive
  • temporarily relieves nasal congestion due to:
  • common cold
  • hay fever
  • upper respiratory allergies
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
  • temporarily relieves sinus congestion and pressure

Purpose

Expectorant and Nasal Decongestant

Dosage and administration

Directions

  • do not crush, chew, or break extended-release tablet
  • take with a full glass of water
  • this product can be administered without regard for timing of meals
  • children under 12 years of age: do not use For 600 mg/60 mg
  • adults and children 12 years and older: 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours For 1200 mg/120 mg
  • adults and children 12 years and older: 1 extended-release tablet every 12 hours; not more than 2 extended-release tablets in 24 hours

Warnings

Do not use 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

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough accompanied by too much phlegm (mucus) When using this product
  • do not use more than directed Stop use and ask doctor if
  • you get nervous, dizzy, or sleepless
  • symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness. Pregnancy/Breastfeeding 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 (1-800-222-1222).

Do not use

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

Ask a doctor before use if

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough accompanied by too much phlegm (mucus)

When using this product

this product

  • do not use more than directed

Stop use and ask a doctor if

and ask doctor if

  • you get nervous, dizzy, or sleepless
  • symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness.

Pregnancy or breast-feeding

Pregnancy/Breastfeeding ask a health professional before use.

Active ingredient (label)

(s) Guaifenesin USP, 600 mg................................................................................Expectorant Pseudoephedrine HCl USP, 60 mg......................................................Nasal Decongestant Guaifenesin USP, 1200 mg................................................................................Expectorant Pseudoephedrine HCl USP, 120 mg......................................................Nasal Decongestant

Inactive ingredients

s FD & C yellow #6, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide.

Storage and handling

Storage

  • store between 20°-25°C (68°-77°F)

Keep out of reach of children

of children In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).