GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED RELEASE- guaifenesin, pseudoephedrine hydrochloride tablet, extended release

Guaifenesin and pseudoephedrine hydrochloride Extended Release by

Drug Labeling and Warnings

Guaifenesin and pseudoephedrine hydrochloride Extended Release by is a Otc medication manufactured, distributed, or labeled by Proficient Rx LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED RELEASE 
guaifenesin, pseudoephedrine hydrochloride tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63187-960(NDC:45802-230)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	600 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	60 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
COPOVIDONE K25-31 (UNII: D9C330MD8B)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	ORANGE (peach)	Score	no score
Shape	OVAL (biconvex)	Size	18mm
Flavor		Imprint Code	600;Watson
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63187-960-18	18 in 1 CARTON	01/01/2018
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091071	01/29/2016

Labeler - Proficient Rx LP (079196022)

Establishment
Name	Address	ID/FEI	Business Operations
Proficient Rx LP		079196022	RELABEL(63187-960)