Guaifenesin D

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (600 mg) Pseudoephedrine (60 mg)

Inactive Ingredients

Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked) Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance

Imprint: 058 Shape: oval Color: white Size: 16 mm Score: 1

Marketing Status

ANDA Active Since 2021-05-06

Medication Information

Description

Drug Facts

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 42229-5

Drug Facts

Section 50565-1

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).

Section 50570-1

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.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Active ingredients (in each extended-release tablet)	Purposes
Guaifenesin 600 mg	Expectorant
Pseudoephedrine HCl 60 mg	Nasal Decongestant

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
adults and children 12 years and older: 2 extended-release tablets every 12 hours; not more than 4 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.

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

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.

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)

Principal Display Panel 36 Tablet Blister Pack Carton

CVS

Health_®

Compare to the active ingredients

in Mucinex^® D Tablets*

NDC 51316-993-36

Extended-Release Tablets

Mucus D

GUAIFENESIN 600 mg &

PSEUDOEPHEDRINE HCl 60 mg

EXTENDED-RELEASE TABLETS

EXPECTORANT &

NASAL DECONGESTANT

Clears nasal/sinus congestion
Thins & loosens mucus
Immediate & extended

release

12

HOUR

Actual Size

36 EXTENDED-RELEASE TABLETS

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 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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).

Section 50570-1 (50570-1)

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.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Active ingredients (in each extended-release tablet)	Purposes
Guaifenesin 600 mg	Expectorant
Pseudoephedrine HCl 60 mg	Nasal Decongestant

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
adults and children 12 years and older: 2 extended-release tablets every 12 hours; not more than 4 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.

Other Information (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 (Inactive ingredients)

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

When Using This Product (When using this product)

do not use more than directed

Stop Use and Ask A Doctor If (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.

Ask A Doctor Before Use If You Have (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)

Principal Display Panel 36 Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 36 Tablet Blister Pack Carton)

CVS

Health_®

Compare to the active ingredients

in Mucinex^® D Tablets*

NDC 51316-993-36

Extended-Release Tablets

Mucus D

GUAIFENESIN 600 mg &

PSEUDOEPHEDRINE HCl 60 mg

EXTENDED-RELEASE TABLETS

EXPECTORANT &

NASAL DECONGESTANT

Clears nasal/sinus congestion
Thins & loosens mucus
Immediate & extended

release

12

HOUR

Actual Size

36 EXTENDED-RELEASE TABLETS

Advanced Ingredient Data

[{"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, UNSPECIFIED", "unii": "3NXW29V3WO", "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": ""}]

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", "42229-5": "Drug Facts", "50565-1": "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).", "50570-1": "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.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Active ingredients (in each extended-release tablet) Purposes Guaifenesin 600 mg Expectorant Pseudoephedrine HCl 60 mg Nasal Decongestant", "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 adults and children 12 years and older: 2 extended-release tablets every 12 hours; not more than 4 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.", "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", "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.", "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)", "PRINCIPAL DISPLAY PANEL - 36 Tablet Blister Pack Carton": "CVS Health ® Compare to the active ingredients in Mucinex ® D Tablets* NDC 51316-993-36 Extended-Release Tablets Mucus D GUAIFENESIN 600 mg & PSEUDOEPHEDRINE HCl 60 mg EXTENDED-RELEASE TABLETS EXPECTORANT & NASAL DECONGESTANT Clears nasal/sinus congestion Thins & loosens mucus Immediate & extended release 12 HOUR Actual Size 36 EXTENDED-RELEASE TABLETS"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information