Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (600 mg) Pseudoephedrine (60 mg)

Inactive Ingredients

Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked) Magnesium Stearate Hypromellose 2910 (10000 Mpa.s) Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance

Imprint: 057 Shape: oval Color: white Size: 17 mm Size: 22 mm Score: 1

Marketing Status

ANDA Active Since 2021-04-01

Medication Information

Description

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

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

Section 55105-1

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

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.

Directions

do not crush, chew, or break extended-release 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 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours
For 1200 mg/120 mg: adults and children 12 years and older: 1 extended-release tablet every 12 hours; not more than 2 extended-release tablets in 24 hours
children under 12 years of age: do not use

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

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

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

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

18 Extended-Release 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 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

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

12 Extended-Release Tablets

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

Structured Label Content

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

Section 55105-1 (55105-1)

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

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.

Directions

do not crush, chew, or break extended-release 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 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours
For 1200 mg/120 mg: adults and children 12 years and older: 1 extended-release tablet every 12 hours; not more than 2 extended-release tablets in 24 hours
children under 12 years of age: do not use

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

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

Guaifenesin 600 Mg and Pseudoephedrine Hcl 60 Mg Extended Release Tablets Carton Label (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

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

18 Extended-Release 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 Tablets Carton Label (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

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

12 Extended-Release Tablets

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

Advanced Ingredient Data

[{"name": "CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)", "unii": "HHT01ZNK31", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE 2910 (10000 MPA.S)", "unii": "0HO1H52958", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "600", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "PSEUDOEPHEDRINE", "unii": "7CUC9DDI9F", "classCode": "ACTIB", "strengthNumerator": "60", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)", "unii": "HHT01ZNK31", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE 2910 (10000 MPA.S)", "unii": "0HO1H52958", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "1200", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "PSEUDOEPHEDRINE", "unii": "7CUC9DDI9F", "classCode": "ACTIB", "strengthNumerator": "120", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"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", "55105-1": "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", "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.", "Directions": "do not crush, chew, or break extended-release 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 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours For 1200 mg/120 mg: adults and children 12 years and older: 1 extended-release tablet every 12 hours; not more than 2 extended-release tablets in 24 hours children under 12 years of age: do not use", "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", "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", "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 Clears Nasal/Sinus Congestion Thins and Loosens Mucus Immediate and Extended Release 18 Extended-Release 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 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 Clears Nasal/Sinus Congestion Thins and Loosens Mucus Immediate and Extended Release 12 Extended-Release Tablets †Ohm ® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners."}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information