guaifenesin

FDA Drug Profile — Rugby Mucus Relief ER, equate mucus relief, mucus relief, mucus extended release, mucus er

Drug Details

Generic Name
guaifenesin
Brand Names
Rugby Mucus Relief ER, equate mucus relief, mucus relief, mucus extended release, mucus er, MUCUS AND CHEST CONGESTION, MUCUS RELIEF, Leader Mucus Relief, foster and thrive mucus relief, Good Sense Mucus ER, mucus, Good Neighbor Pharmacy Mucus ER, DG health mucus er max, UP AND UP MUCUS RELIEF, Topcare Mucus ER, up and up mucus relief, GUAIFENESIN, equate mucus-er, basic care mucus er max, DG Health Mucus ER, Topcare mucus er, good sense mucus er
Application Number
ANDA078912
Sponsor
Rugby Laboratories
NDC Codes
26
Dosage Forms
TABLET, MULTILAYER, EXTENDED RELEASE, TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients
GUAIFENESIN

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

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 ■ 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).