The following Structured Product Label (SPL) was submitted to the FDA by Dr. Reddys Laboratories Limited for the product Guaifenesin And Pseudoephedrine Hcl (NDC 55111-798). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient(s), purpose, use(s), warnings, do not use, ask a doctor before use if, when using this product, stop use and ask doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Guaifenesin USP, 600 mg................................................................................Expectorant
Pseudoephedrine HCl USP, 60 mg......................................................Nasal Decongestant
Guaifenesin USP, 1200 mg................................................................................Expectorant
Pseudoephedrine HCl USP, 120 mg......................................................Nasal Decongestant
Expectorant and Nasal Decongestant
■ 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
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.
■ 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)
■ do not use more than directed
■ 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.
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
■ 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
■ children under 12 years of age: do not use
For 600 mg/60 mg
■ adults and children 12 years and older: 2 tablets every 12 hours; not more than 4 tablets in 24 hours
For 1200 mg/120 mg
■ adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
■ 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)
FD & C yellow #6, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide.
call 1-888-375-3784
You may also report side effect to this phone number.
Keep the carton.
It contains important information.
See end panel for expiration date.
Manufactured by:
Dr. Reddy’s Laboratories Limited
Srikakulam – 532 409 INDIA
Guaifenesin and Pseudoephedrine HCl ER Tablets 600 mg/60 mg:
Carton1 (Carton1)
* Please review the disclaimer below.
