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← See all Guaifenesin and pseudoephedrine hydrochloride Extended Release brands

Guaifenesin and pseudoephedrine hydrochloride Extended Release

Medically reviewed on January 2, 2018

Dosage form: tablet, extended release
Ingredients: GUAIFENESIN 600mg, PSEUDOEPHEDRINE HYDROCHLORIDE 60mg
Labeler: Proficient Rx LP
NDC Code: 63187-960

Perrigo Guaifenesin and Pseudoephedrine Hydrochloride Extended-Release Tablets Drug Facts

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

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 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

GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED RELEASE 
guaifenesin, pseudoephedrine hydrochloride tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-960(NDC:45802-230)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN600 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
COPOVIDONE K25-31 
MAGNESIUM STEARATE 
HYPROMELLOSE, UNSPECIFIED 
MALTODEXTRIN 
MICROCRYSTALLINE CELLULOSE 
POVIDONE, UNSPECIFIED 
STEARIC ACID 
Product Characteristics
ColorORANGE (peach) Scoreno score
ShapeOVAL (biconvex) Size18mm
FlavorImprint Code600;Watson
Contains    
Packaging
#Item CodePackage Description
1NDC:63187-960-1818 BLISTER PACK in 1 CARTON
11 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09107101/29/2016
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIOperations
Proficient Rx LP079502574RELABEL(63187-960)

 
Proficient Rx LP

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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