Guaifenesin and Pseudoephedrine HCl by Ohm Laboratories, Inc. Drug Facts

Guaifenesin and Pseudoephedrine HCl by

Drug Labeling and Warnings

Guaifenesin and Pseudoephedrine HCl by is a Otc medication manufactured, distributed, or labeled by Ohm Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 useif 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: 51660-057
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 CARTON04/01/202104/01/2021
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21254204/01/202104/01/2021
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 CARTON04/01/202104/01/2021
118 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21254204/01/202104/01/2021
Labeler - Ohm Laboratories, Inc. (184769029)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories, Inc.184769029manufacture(51660-058, 51660-057)

Revised: 11/2024
 

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