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 tablet)

Purposes

Guaifenesin 600 mg

Expectorant

Pseudoephedrine HCl 60 mg

Nasal Decongestant

Active ingredients (in each extended-release tablet)

Purposes

Guaifenesin 1200 mg

Expectorant

Pseudoephedrine HCl 120 mg

Nasal Decongestant

Uses

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

When using this product

Stop use and ask a doctor if

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

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; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF

Questions?

call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 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

0321

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

NDC 51660-074-18

Compare To
the active ingredients of
Mucinex ®D

ohm ®

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

Expectorant & Nasal Decongestant

12 Hour

18 Extended-Release Tablets

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

guaif-pseuso

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

NDC 51660-077-12

Compare To
the active ingredients of

Maximum Strength
Mucinex ®D

ohm ®

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

Expectorant & Nasal Decongestant

12 Hour

12 Extended-Release Tablets

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

guai-pseudo-02

GUAIFENESIN AND PSEUDOEPHEDRINE HCL 
guaifenesin and pseudoephedrine hcl tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51660-074
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)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYPROMELLOSE 2910 (10000 MPA.S) (UNII: 0HO1H52958)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Product Characteristics
Colorwhite (white to off-white) Scoreno score
ShapeOVALSize17mm
FlavorImprint Code 058
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51660-074-181 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:51660-077
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN1200 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE120 mg
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
HYPROMELLOSE 2910 (10000 MPA.S) (UNII: 0HO1H52958)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Product Characteristics
Colorwhite (white to off-white) Scoreno score
ShapeOVALSize22mm
FlavorImprint Code 057
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51660-077-121 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(51660-074, 51660-077)

Revised: 10/2024
Document Id: 2522057d-9a67-f0f3-e063-6394a90af3f5
Set id: 2521ecd3-28f3-a13c-e063-6394a90a7245
Version: 1
Effective Time: 20241023
 
Ohm Laboratories, Inc.