GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE- guaifenesin and pseudoephedrine hydrochloride tablet, extended release 
OHM LABORATORIES INC

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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

Compare To
the active ingredients of
Mucinex® D

NDC 51660-071-36

ohm®

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

Expectorant & Nasal Decongestant

12 Hour

36 Extended-Release Tablets

PRINCIPAL DISPLAY PANEL - 600 mg/60 mg Tablet Blister Pack Carton
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE 
guaifenesin and pseudoephedrine hydrochloride tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51660-071
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin600 mg
Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) Pseudoephedrine Hydrochloride60 mg
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize16mm
FlavorImprint Code xeuMnci;600
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51660-071-181 in 1 CARTON12/10/2017
118 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:51660-071-362 in 1 CARTON12/10/2017
218 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02158511/15/2017
Labeler - OHM LABORATORIES INC (184769029)
Establishment
NameAddressID/FEIBusiness Operations
RECKITT BENCKISER HEALTHCARE INTERNATIONAL LTD230780363MANUFACTURE(51660-071)

Revised: 6/2019
Document Id: e0cbdc72-78c1-4372-a09d-de74c383dbbf
Set id: 400252ae-fe27-4f82-87f3-ead7eff335de
Version: 5
Effective Time: 20190621
 
OHM LABORATORIES INC