FDA Label for Guaifenesin And Pseudoephedrine Hydrochloride Extended Release
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH EXTENDED-RELEASE TABLET)
- PURPOSE
- USES
- DO NOT USE IF YOU ARE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Guaifenesin And Pseudoephedrine Hydrochloride Extended Release Product Label
The following document was submitted to the FDA by the labeler of this product Proficient Rx Lp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients (In Each Extended-Release Tablet)
Guaifenesin 600 mg
Pseudoephedrine HCl 60 mg
Purpose
Expectorant
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
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)
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
Other Information
• store between 20-25°C (68-77°F)• do not use if blister unit is broken or torn
Inactive Ingredients
colloidal silicon dioxide, copovidone, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid
Questions Or Comments?
1-800-719-9260
Package/Label Principal Display Panel
Compare to Mucinex® D active ingredient
Guaifenesin and Pseudoephedrine Hydrochloride Extended-Release Tablets, 600 mg/60 mg
Expectorant/Nasal Decongestant
12 HOUR
Clears Nasal/Sinus Congestion
Thins and Loosens Mucus
Actual Size
18 Extended-Release Tablets
Relabeled by:
Proficient Rx LP
Thousand Oaks, CA 91320
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