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NDC 63187-0960-18 Guaifenesin and pseudoephedrine hydrochloride Extended Release 600; 60 mg/1; mg/1 Details

Guaifenesin and pseudoephedrine hydrochloride Extended Release 600; 60 mg/1; mg/1

Guaifenesin and pseudoephedrine hydrochloride Extended Release is a ORAL TABLET, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.

Related Packages: 63187-0960-18
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin

Pseudoephedrine is used to relieve nasal congestion caused by colds, allergies, and hay fever. It is also used to temporarily relieve sinus congestion and pressure. Pseudoephedrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Pseudoephedrine is in a class of medications called nasal decongestants. It works by causing narrowing of the blood vessels in the nasal passages.

Related Packages: 63187-0960-18
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Pseudoephedrine

Product Information

NDC	63187-0960
Product ID	63187-960_474280cc-828d-4cfc-96ae-08a47e64d320
Associated GPIs	43996202307435
GCN Sequence Number	012073
GCN Sequence Number Description	guaifenesin/pseudoephedrne HCl TAB ER 12H 600MG-60MG ORAL
HIC3	B4W
HIC3 Description	DECONGESTANT-EXPECTORANT COMBINATIONS
GCN	54980
HICL Sequence Number	000270
HICL Sequence Number Description	GUAIFENESIN/PSEUDOEPHEDRINE HCL
Brand/Generic	Generic
Proprietary Name	Guaifenesin and pseudoephedrine hydrochloride Extended Release
Proprietary Name Suffix	n/a
Non-Proprietary Name	Guaifenesin, pseudoephedrine hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, EXTENDED RELEASE
Route	ORAL
Active Ingredient Strength	600; 60
Active Ingredient Units	mg/1; mg/1
Substance Name	GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Labeler Name	Proficient Rx LP
Pharmaceutical Class	Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA091071
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63187-0960-18 (63187096018)

Pricing Information	N/A
NDC Package Code	63187-960-18
Billing NDC	63187096018
Package	18 BLISTER PACK in 1 CARTON (63187-960-18) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date	2018-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a4a9f535-3674-450c-b84b-b65ca1654cfb Details

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA091071	01/29/2016

Labeler - Proficient Rx LP (079196022)

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

Revised: 11/2019

Document Id: 474280cc-828d-4cfc-96ae-08a47e64d320

Set id: a4a9f535-3674-450c-b84b-b65ca1654cfb

Version: 3

Effective Time: 20191101