Mucinex ®

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (600 mg)

Inactive Ingredients

Fd&c Blue No. 1 Aluminum Oxide Hypromelloses Magnesium Stearate Cellulose, Microcrystalline Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked)

Identifiers & Packaging

Pill Appearance

Imprint: Mucinex;600 Shape: oval Color: white Size: 16 mm Score: 1

Marketing Status

NDA Active Since 2016-02-19

Medication Information

Purpose

Expectorant

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

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.

Section 53414-9

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

Directions

do not crush, chew, or break tablet
take with a full glass of water
this product can be administered without regard for the timing of meals
adults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours.
children under 12 years of age: do not use

Do Not Use

for children under 12 years of age

Questions?

1-866-MUCINEX (1-866-682-4639) for information about the drug product or to report side effects. For information about packaging, contact American Health Packaging at 1-800-707-4621.

Active Ingredient

Guaifenesin 600 mg

Other Information

FOR YOUR PROTECTION: Do not use if blister is torn or broken.
store between 20-25°C (68-77°F)

Inactive Ingredients

carbomer homopolymer type B; FD&C blue #1 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Stop Use and Ask A Doctor If

cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

Ask A Doctor Before Use If You Have

persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
cough accompanied by too much phlegm (mucus)

Principal Display Panel – Carton – 600 Mg

NDC 68084-572-01

Mucinex ^®

600 mg guaifenesin

extended-release bi-layer tablets

EXPECTORANT

100 Tablets (10 x 10)

Principal Display Panel – Blister – 600 Mg

Mucinex ^® (guaifenesin)

EXPECTORANT extended-

release bi-layer tablet 600 mg

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

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.

Section 53414-9 (53414-9)

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

Purpose

Expectorant

Directions

do not crush, chew, or break tablet
take with a full glass of water
this product can be administered without regard for the timing of meals
adults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours.
children under 12 years of age: do not use

Do Not Use (Do not use)

for children under 12 years of age

Questions?

1-866-MUCINEX (1-866-682-4639) for information about the drug product or to report side effects. For information about packaging, contact American Health Packaging at 1-800-707-4621.

Active Ingredient (Active ingredient)

Guaifenesin 600 mg

Other Information (Other information)

FOR YOUR PROTECTION: Do not use if blister is torn or broken.
store between 20-25°C (68-77°F)

Inactive Ingredients (Inactive ingredients)

carbomer homopolymer type B; FD&C blue #1 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

cough lasts more than 7 days, comes back, or occurs with 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)

persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
cough accompanied by too much phlegm (mucus)

Principal Display Panel – Carton – 600 Mg (Principal Display Panel – Carton – 600 mg)

NDC 68084-572-01

Mucinex ^®

600 mg guaifenesin

extended-release bi-layer tablets

EXPECTORANT

100 Tablets (10 x 10)

Principal Display Panel – Blister – 600 Mg (Principal Display Panel – Blister – 600 mg)

Mucinex ^® (guaifenesin)

EXPECTORANT extended-

release bi-layer tablet 600 mg

Advanced Ingredient Data

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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", "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.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Expectorant", "Directions": "do not crush, chew, or break tablet take with a full glass of water this product can be administered without regard for the timing of meals adults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours. children under 12 years of age: do not use", "Do not use": "for children under 12 years of age", "Questions?": "1-866-MUCINEX (1-866-682-4639) for information about the drug product or to report side effects. For information about packaging, contact American Health Packaging at 1-800-707-4621.", "Active ingredient": "Guaifenesin 600 mg", "Other information": "FOR YOUR PROTECTION: Do not use if blister is torn or broken. store between 20-25°C (68-77°F)", "Inactive ingredients": "carbomer homopolymer type B; FD&C blue #1 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF", "Stop use and ask a doctor if": "cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.", "Ask a doctor before use if you have": "persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough accompanied by too much phlegm (mucus)", "Principal Display Panel – Carton – 600 mg": "NDC 68084-572-01 Mucinex ® 600 mg guaifenesin extended-release bi-layer tablets EXPECTORANT 100 Tablets (10 x 10)", "Principal Display Panel – Blister – 600 mg": "Mucinex ® (guaifenesin) EXPECTORANT extended- release bi-layer tablet 600 mg"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information