Drug Facts
19cde6f8-649a-df69-7ee9-05da2cccba5b
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
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, 1200 mg................................................................................Expectorant Pseudoephedrine HCl USP, 120 mg......................................................Nasal Decongestant
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
Warnings
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: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
- children under 12 years of age: 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.
Questions?
call 1-888-375-3784
You may also report side effect to this phone number.
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)
Inactive Ingredients
FD & C yellow #6, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide.
Principal Display Panel
Guaifenesin and Pseudoephedrine HCl ER Tablets 1200 mg/120 mg:
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.
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).
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)
Active Ingredients (in Each Extended Release Tablet)
Guaifenesin USP, 1200 mg................................................................................Expectorant
Pseudoephedrine HCl USP, 120 mg......................................................Nasal Decongestant
Structured Label Content
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
Purpose
Expectorant and Nasal Decongestant
Warnings
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: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
- children under 12 years of age: do not use
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.
Questions?
call 1-888-375-3784
You may also report side effect to this phone number.
Other Information (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)
Inactive Ingredients (Inactive ingredients)
FD & C yellow #6, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide.
Principal Display Panel
Guaifenesin and Pseudoephedrine HCl ER Tablets 1200 mg/120 mg:
When Using This Product (When using this product)
- do not use more than directed
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.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)
ask a health professional before use.
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).
Ask A Doctor Before Use If You Have (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)
Active Ingredients (in Each Extended Release Tablet) (Active ingredients (in each extended-release tablet))
Guaifenesin USP, 1200 mg................................................................................Expectorant
Pseudoephedrine HCl USP, 120 mg......................................................Nasal Decongestant
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:07:35.482122 · Updated: 2026-03-14T23:11:13.760766