Drugplain

Guaifenesin and Pseudoephedrine HCl 600 mg/1

Guaifenesin and Pseudoephedrine HCl · TABLET, EXTENDED RELEASE · Granules India Ltd

No Recall History
Plain English

Guaifenesin and Pseudoephedrine HCl is a tablet, extended release containing guaifenesin and pseudoephedrine hcl at 600 mg/1, taken oral. Manufactured by Granules India Ltd.

Key Facts

Brand Name
Guaifenesin and Pseudoephedrine HCl
Generic Name
Guaifenesin and Pseudoephedrine HCl
NDC Code (Product)
62207-827
Manufacturer
Granules India Ltd
Strength
600 mg/1
Dosage Form
TABLET, EXTENDED RELEASE
Route
ORAL
Marketing Status
Application #
ANDA216082
Drug Class
Expectorant [EPC]
Marketing Start
06/01/2023

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

alanine aminotransferase increased1 reports
arthritis1 reports
aspartate aminotransferase increased1 reports
blood alkaline phosphatase increased1 reports
blood chloride decreased1 reports
blood cholesterol increased1 reports
blood sodium decreased1 reports
bronchitis1 reports
cholelithiasis1 reports
deep vein thrombosis1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome 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

Dosage & 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 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 children under 12 years of age: do not use Other Information Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing. store between 20-25°C (68-77°F)

Warnings

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 you have 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 a 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. 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 (1-800-222-1222).

Frequently Asked Questions

What is Guaifenesin and Pseudoephedrine HCl used for?

Guaifenesin and Pseudoephedrine HCl contains Guaifenesin and Pseudoephedrine HCl. It is a tablet, extended release taken oral. Consult your doctor for specific uses.

Is Guaifenesin and Pseudoephedrine HCl a controlled substance?

Guaifenesin and Pseudoephedrine HCl is not classified as a controlled substance by the DEA.

What is the generic name for Guaifenesin and Pseudoephedrine HCl?

The generic name for Guaifenesin and Pseudoephedrine HCl is Guaifenesin and Pseudoephedrine HCl. There are 4 other brand versions of Guaifenesin and Pseudoephedrine HCl.

What is the NDC code for Guaifenesin and Pseudoephedrine HCl 600 mg/1?

The NDC (National Drug Code) for Guaifenesin and Pseudoephedrine HCl 600 mg/1 is 62207-827, listed by Granules India Ltd.

Product NDC

62207-827

Package NDC

62207-827-72

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)