Drug Facts
51ec068b-e219-381a-384b-a208a306d5ba
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Guaifenesin USP, 600 mg................................................................................Expectorant Pseudoephedrine HCl USP, 60 mg......................................................Nasal Decongestant Guaifenesin USP, 1200 mg................................................................................Expectorant Pseudoephedrine HCl USP, 120 mg......................................................Nasal Decongestant
Purpose
Expectorant and Nasal Decongestant
Medication Information
Purpose
Expectorant and Nasal Decongestant
Description
Guaifenesin USP, 600 mg................................................................................Expectorant Pseudoephedrine HCl USP, 60 mg......................................................Nasal Decongestant Guaifenesin USP, 1200 mg................................................................................Expectorant Pseudoephedrine HCl USP, 120 mg......................................................Nasal Decongestant
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
Storage
■ store between 20°-25°C (68°-77°F)
Warnings
Questions
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
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
■ children under 12 years of age: do not use
■ adults and children 12 years and older: 2 tablets every 12 hours; not more than 4 tablets in 24 hours
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.
Other Information
■ tamper evident: do not use if carton is open or if printed seal on blister is broken or missing.
Active Ingredient(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
FD & C yellow #6, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide.
Pregnancy/breastfeeding
ask a health professional before use.
Principal Display Panel
Guaifenesin and Pseudoephedrine HCl ER Tablets 600 mg/60 mg:
When Using This Product
■ do not use more than directed
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)
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.
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).
Structured Label Content
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
Storage
■ store between 20°-25°C (68°-77°F)
Warnings
Questions
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
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
■ children under 12 years of age: do not use
■ adults and children 12 years and older: 2 tablets every 12 hours; not more than 4 tablets in 24 hours
Do Not Use (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.
Other Information (Other information)
■ tamper evident: do not use if carton is open or if printed seal on blister is broken or missing.
Active Ingredient(s) (Active ingredient(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 (Inactive ingredients)
FD & C yellow #6, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide.
Pregnancy/breastfeeding (Pregnancy/Breastfeeding)
ask a health professional before use.
Principal Display Panel
Guaifenesin and Pseudoephedrine HCl ER Tablets 600 mg/60 mg:
When Using This Product (When using this product)
■ do not use more than directed
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)
Stop Use and Ask Doctor If (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.
Keep Out of Reach of Children (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).
Advanced Ingredient Data
Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:07:36.798829 · Updated: 2026-03-14T23:11:16.641314