Drugplain

Guaifenesin and Pseudoephedrine Hydrochloride 600 mg/1

Guaifenesin and Pseudoephedrine Hydrochloride · TABLET, EXTENDED RELEASE · STRATEGIC SOURCING SERVICES LLC

No Recall History
Plain English

Guaifenesin and Pseudoephedrine Hydrochloride is a tablet, extended release containing guaifenesin and pseudoephedrine hydrochloride at 600 mg/1, taken oral. Manufactured by STRATEGIC SOURCING SERVICES LLC.

Key Facts

Brand Name
Guaifenesin and Pseudoephedrine Hydrochloride
Generic Name
Guaifenesin and Pseudoephedrine Hydrochloride
NDC Code (Product)
62011-0475
Manufacturer
STRATEGIC SOURCING SERVICES LLC
Strength
600 mg/1
Dosage Form
TABLET, EXTENDED RELEASE
Route
ORAL
Marketing Status
Application #
ANDA212542
Drug Class
Expectorant [EPC]
Marketing Start
11/15/2017

Recall History

No Recall History

Side Effects Reported to FDA

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

myocardial infarction4 reports
pain4 reports
anxiety3 reports
cholecystitis chronic3 reports
death3 reports
deep vein thrombosis3 reports
injury3 reports
pneumonia3 reports
pulmonary embolism3 reports
arthralgia2 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 tablet • take with a full glass of water • this product can be administered without regard for timing of meals • adults and children 12 years and older: 2 tablets every 12 hours; not more than 4 tablets in 24 hours • children under 12 years of age: do not use

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 Hydrochloride used for?

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

Is Guaifenesin and Pseudoephedrine Hydrochloride a controlled substance?

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

What is the generic name for Guaifenesin and Pseudoephedrine Hydrochloride?

The generic name for Guaifenesin and Pseudoephedrine Hydrochloride is Guaifenesin and Pseudoephedrine Hydrochloride. There are 10 other brand versions of Guaifenesin and Pseudoephedrine Hydrochloride.

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

The NDC (National Drug Code) for Guaifenesin and Pseudoephedrine Hydrochloride 600 mg/1 is 62011-0475, listed by STRATEGIC SOURCING SERVICES LLC.

Product NDC

62011-0475

Package NDC

62011-0475-1

Other Guaifenesin and Pseudoephedrine Hydrochloride Dosages

Other Guaifenesin Brands

See all →

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

Data from openFDA · Public domain (CC0 1.0)