FDA Label for Guaifenesin And Pseudoephedrine Hcl
View Indications, Usage & Precautions
Guaifenesin And Pseudoephedrine Hcl Product Label
The following document was submitted to the FDA by the labeler of this product Granules India Ltd. 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 Ingrediens
(in each extended-release tablet)
Guaifenesin USP, 600 mg
Pseudoephedrine HCL USP, 60 mg
Guaifenesin USP, 1200 mg
Pseudoephedrine HCL USP, 120 mg
Purposes
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
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 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 Centre 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:
For 600mg and 60mg: 2 tablets every 12 hours; not more than 4 tablets in 24 hours
For 1200mg and 120mg: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
• children under 12 years of age: do not use
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
carbomer homopolymer Type B, cellulose microcrystalline, hypromellose, lake of FD&C yellow 6, magnesium stearate, sodium starch glycolate Type A
Questions Or Comments
Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.
You may also report side effects to this phone number.
Keep the carton.
It contains important information. See end panel for
expiration date.
Manufactured By:
Granules India Limited
Hyderabad – 500 081, INDIA
MADE IN INDIA
Distributed By:
Granules USA, Inc.
Parsippany, NJ 07054
Principal Display Panel
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