DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (600 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

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

Marketing Status

ANDA Active Since 2020-05-08

Medication Information

Warnings and Precautions

Warnings

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 (1-800-222-1222) right away.

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

Questions?

Call toll-free 1-800-630-8895

Active Ingredient

Guaifenesin 600 mg

Other Information

■ store between 20º to 25ºC (68º to 77ºF)

■ DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Inactive Ingredients

carbomer homopolymer type B, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.

Principal Display Panel

NDC 80513-403-20

*Compare to the active ingredient in Mucinex ^®

Mucus Relief

Guaifenesin 600 mg

Expectorant

EXTENDED-RELEASE TABLETS BI-LAYER TABLETS

200 Tablets

*This product is not manufactured or distributed by the owner of the registered trademark Mucinex ^®Extended-Release 600 mg 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

Warnings and Precautions (34071-1)

Warnings

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 (1-800-222-1222) right away.

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

Questions?

Call toll-free 1-800-630-8895

Active Ingredient (Active ingredient)

Guaifenesin 600 mg

Other Information (Other information)

■ store between 20º to 25ºC (68º to 77ºF)

■ DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Inactive Ingredients (Inactive ingredients)

carbomer homopolymer type B, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 80513-403-20

*Compare to the active ingredient in Mucinex ^®

Mucus Relief

Guaifenesin 600 mg

Expectorant

EXTENDED-RELEASE TABLETS BI-LAYER TABLETS

200 Tablets

*This product is not manufactured or distributed by the owner of the registered trademark Mucinex ^®Extended-Release 600 mg Tablets

Advanced Ingredient Data

[{"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": "SODIUM STARCH GLYCOLATE TYPE A", "unii": "H8AV0SQX4D", "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": "600", "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", "34071-1": "Warnings", "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 (1-800-222-1222) right away.", "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", "Questions?": "Call toll-free 1-800-630-8895", "Active ingredient": "Guaifenesin 600 mg", "Other information": "■ store between 20º to 25ºC (68º to 77ºF) ■ DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED", "Inactive ingredients": "carbomer homopolymer type B, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.", "PRINCIPAL DISPLAY PANEL": "NDC 80513-403-20 *Compare to the active ingredient in Mucinex ® Mucus Relief Guaifenesin 600 mg Expectorant EXTENDED-RELEASE TABLETS BI-LAYER TABLETS 200 Tablets *This product is not manufactured or distributed by the owner of the registered trademark Mucinex ® Extended-Release 600 mg Tablets"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information