Mucinex®

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (600 mg)

Inactive Ingredients

Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked) Fd&c Blue No. 1 Hypromelloses Magnesium Stearate Cellulose, Microcrystalline Sodium Starch Glycolate Type A Potato

Identifiers & Packaging

Pill Appearance

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

Marketing Status

NDA Active Since 2013-01-01

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 50566-9

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.

Section 50569-3

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)

Section 50570-1

Do not use

for children under 12 years of age

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

Package Label

Label Image for 53808-0871

600mg

Other Information

store between 20-25°C (68-77°F)
see window for lot number and expiration date

Questions? 1-866-MUCINEX (1-866-682-4639)

You may also report side effects to this phone number

Please visit our web site www.mucinex.com

US Pat. 6,372,252 B1

US Pat. 6,955,821 B2

Inactive Ingredients

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

Keep Out of Reach of Children

Keep out of reach of children. This package is intended for institutional use only. This package is not child resistant. In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Extended Release Bi Layer Tablet)

Guaifenesin 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 50566-9 (50566-9)

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.

Section 50569-3 (50569-3)

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)

Section 50570-1 (50570-1)

Do not use

for children under 12 years of age

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

Package Label (PACKAGE LABEL)

Label Image for 53808-0871

600mg

Other Information (Other information)

store between 20-25°C (68-77°F)
see window for lot number and expiration date

Questions? 1-866-MUCINEX (1-866-682-4639)

You may also report side effects to this phone number

Please visit our web site www.mucinex.com

US Pat. 6,372,252 B1

US Pat. 6,955,821 B2

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

Keep Out of Reach of Children

Keep out of reach of children. This package is intended for institutional use only. This package is not child resistant. In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Extended Release Bi Layer Tablet) (Active ingredient (in each extended-release bi-layer tablet))

Guaifenesin 600 mg

Advanced Ingredient Data

[{"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "600", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)", "unii": "HHT01ZNK31", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSES", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "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", "42229-5": "Drug Facts", "50566-9": "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.", "50569-3": "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)", "50570-1": "Do not use for children under 12 years of age", "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", "PACKAGE LABEL": "Label Image for 53808-0871 600mg", "Other information": "store between 20-25°C (68-77°F) see window for lot number and expiration date Questions? 1-866-MUCINEX (1-866-682-4639) You may also report side effects to this phone number Please visit our web site www.mucinex.com US Pat. 6,372,252 B1 US Pat. 6,955,821 B2", "Inactive ingredients": "carbomer homopolymer type B, FD&C blue #1 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF", "Keep Out of Reach of Children": "Keep out of reach of children. This package is intended for institutional use only. This package is not child resistant. In case of overdose, get medical help or contact a Poison Control Center right away.", "Active ingredient (in each extended-release bi-layer tablet)": "Guaifenesin 600 mg"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information