GUAIFENESIN AND PSEUDOEPHEDRINE HCL tablet, extended release

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]

ACTIVE INGREDIENT

• 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.

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.

INGREDIENTS AND APPEARANCE

GUAIFENESIN AND PSEUDOEPHEDRINE HCL 
guaifenesin and pseudoephedrine hcl tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51660-058
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	600 mg
PSEUDOEPHEDRINE (UNII: 7CUC9DDI9F) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE	60 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE (white to off-white) , ORANGE (orange to light orange)	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	058
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51660-058-18	1 in 1 CARTON	04/01/2021
1		18 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA212542	04/01/2021

GUAIFENESIN AND PSEUDOEPHEDRINE HCL 
guaifenesin and pseudoephedrine hcl tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51660-057
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	1200 mg
PSEUDOEPHEDRINE (UNII: 7CUC9DDI9F) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE	120 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE (white to off-white) , ORANGE (orange to light orange)	Score	no score
Shape	OVAL	Size	22mm
Flavor		Imprint Code	057
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51660-057-12	1 in 1 CARTON	04/01/2021
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA212542	04/01/2021

Labeler - Ohm Laboratories, Inc. (184769029)

Establishment
Name	Address	ID/FEI	Business Operations
Ohm Laboratories, Inc.		184769029	MANUFACTURE(51660-058, 51660-057)