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Guaifenesin and Pseudoephedrine Hydrochloride

Dosage form: tablet, extended release
Ingredients: Guaifenesin 600mg, Pseudoephedrine Hydrochloride 60mg
Labeler: OHM LABORATORIES INC
NDC Code: 51660-071

Guaifenesin and Pseudoephedrine Hydrochloride

Drug Facts

Active ingredients (in each extended-release tablet)Purposes

Guaifenesin 600 mg

Expectorant

Pseudoephedrine HCl 60 mg

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
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; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Questions?

(1-800-406-7984)

You may also report side effects to this phone number.

Distributed by:
Sun Pharmaceutical Industries, Inc.
Cranbury, NJ 08512

PRINCIPAL DISPLAY PANEL - 600 mg/60 mg Tablet Blister Pack Carton

NDC 51660-071-18

Compare To
the active ingredients of
Mucinex® D

ohm®

Guaifenesin 600 mg
& Pseudoephedrine HCl 60 mg
Extended-Release Tablets

Expectorant & Nasal Decongestant

12 Hour

1.
Clears Nasal/Sinus Congestion
2.
Thins and Loosens Mucus
3.
Immediate and Extended Release

18 Extended-Release Tablets

GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE 
guaifenesin and pseudoephedrine hydrochloride tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51660-071
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
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) 
HYPROMELLOSE, UNSPECIFIED 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize16mm
FlavorImprint CodeMucinex;600
Contains    
Packaging
#Item CodePackage Description
1NDC:51660-071-181 BLISTER PACK in 1 CARTON
118 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
2NDC:51660-071-362 BLISTER PACK in 1 CARTON
218 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02158511/15/2017
Labeler - OHM LABORATORIES INC (184769029)
Establishment
NameAddressID/FEIOperations
RECKITT BENCKISER HEALTHCARE INTERNATIONAL LTD230780363MANUFACTURE(51660-071)

Revised: 10/2017
 
OHM LABORATORIES INC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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