GUAIFENESIN AND PSEUDOEPHEDRINE HCL- guaifenesin and pseudoephedrine hcl tablet, extended release 
Ohm Laboratories, Inc.

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Drug Facts

Active ingredients (in each extended-release bi-layer tablet)

Purposes

Guaifenesin 600 mg

Expectorant

Pseudoephedrine HCl 60 mg

Nasal Decongestant

Active ingredients (in each extended-release bi-layer tablet)

Purposes

Guaifenesin 1200 mg

Expectorant

Pseudoephedrine HCl 120 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 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
For 600 mg/60 mg: adults and children 12 years and older: 2 tablets every 12 hours; not more than 4 tablets in 24 hours
For 1200 mg/120 mg: adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 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, NF; FD&C Yellow #6; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF

Questions?

call 1-800-406-7984

You may also report side effects to this phone number.

Keep the carton. It contains important information.

See end panel for expiration date.

Ohm® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners.

Distributed by:
Ohm Laboratories Inc.
New Brunswick, NJ 08901

0219

Guaifenesin 600 mg and Pseudoephedrine HCl 60 mg Extended-Release Bi-Layer Tablets - Carton Label

NDC 51660-058-18

Compare To
the active ingredients of
Mucinex® D

ohm®

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

Expectorant & Nasal Decongestant

12 Hour

Clears Nasal/Sinus Congestion
Thins and Loosens Mucus
Immediate and Extended Release

18 Extended-Release Bi-Layer Tablets

†Ohm® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners.

600 mg/60 mg Carton Label

Guaifenesin 1200 mg and Pseudoephedrine HCl 120 mg Extended-Release Bi-Layer Tablets - Carton Label

NDC 51660-057-12

Compare To
the active ingredients of
Mucinex® D

ohm®

Maximum Strength
Guaifenesin 1200 mg & Pseudoephedrine HCl 120 mg
Extended-Release Bi-Layer Tablets

Expectorant & Nasal Decongestant

12 Hour

Clears Nasal/Sinus Congestion
Thins and Loosens Mucus
Immediate and Extended Release

12 Extended-Release Bi-Layer Tablets

†Ohm® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners.

1200 mg/120 mg Carton Label
GUAIFENESIN AND PSEUDOEPHEDRINE HCL 
guaifenesin and pseudoephedrine hcl tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51660-058
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
PSEUDOEPHEDRINE (UNII: 7CUC9DDI9F) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE60 mg
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYPROMELLOSE 2910 (10000 MPA.S) (UNII: 0HO1H52958)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Product Characteristics
ColorWHITE (white to off-white) , ORANGE (orange to light orange) Scoreno score
ShapeOVALSize17mm
FlavorImprint Code 058
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51660-058-181 in 1 CARTON04/01/2021
118 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21254204/01/2021
GUAIFENESIN AND PSEUDOEPHEDRINE HCL 
guaifenesin and pseudoephedrine hcl tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51660-057
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN1200 mg
PSEUDOEPHEDRINE (UNII: 7CUC9DDI9F) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE120 mg
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSE 2910 (10000 MPA.S) (UNII: 0HO1H52958)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Product Characteristics
ColorWHITE (white to off-white) , ORANGE (orange to light orange) Scoreno score
ShapeOVALSize22mm
FlavorImprint Code 057
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51660-057-121 in 1 CARTON04/01/2021
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21254204/01/2021
Labeler - Ohm Laboratories, Inc. (184769029)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories, Inc.184769029MANUFACTURE(51660-058, 51660-057)

Revised: 4/2021
Document Id: efb49ad2-ac54-4918-9c5a-7228a6dfa21c
Set id: efb49ad2-ac54-4918-9c5a-7228a6dfa21c
Version: 1
Effective Time: 20210401
 
Ohm Laboratories, Inc.