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SPL v4

SPL

SPL Set ID 33f9c655-87f5-4cbb-889f-fbb3f376b09d

Route

ORAL

Published

Effective Date 2017-07-19

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (400 mg)

Inactive Ingredients

Silicon Dioxide Magnesium Stearate Maltodextrin Microcrystalline Cellulose Povidone, Unspecified Sodium Starch Glycolate Type A Potato Stearic Acid

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2012-04-16

Description

Each immediate release tablet contains: Guaifenesin 400 mg

How Supplied

Product: 50436-6232 NDC: 50436-6232-2 60 TABLET in a BOTTLE

Medication Information

Warnings and Precautions

Ask a doctor berfoe use if you have: Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema; Cough accompanied by excessive phlegm (mucus)

Indications and Usage

Helps loosen phlegm (mucus) and thin

bronchial secretions to make coughts more productive to rid the bronchial passageway of bothersome mucus.

Dosage and Administration

Adults and children 12 years of age and older, take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours. Children under 12 years of age do not use

How Supplied

Product: 50436-6232

NDC: 50436-6232-2 60 TABLET in a BOTTLE

Description

Each immediate release tablet contains: Guaifenesin 400 mg

Section 50565-1

Keep Out of Reach of Children: In case of overdose, get medical help or contact a Poison Control Center

Section 51727-6

Silicon Dioxide, Magnesium Stearate, Maltodextrin, Cellulose, Microcrystalline, Povidone, Sodium Starch Glycolate, Stearic Acid

Section 55105-1

PURPOSE: EXPECTORANT

Section 55106-9

Each immediate release tablet contains: Guaifenesin 400 mg

Mucus Relief (guaifenesin) Tablet

Structured Label Content

Indications and Usage (34067-9)

Helps loosen phlegm (mucus) and thin

bronchial secretions to make coughts more productive to rid the bronchial passageway of bothersome mucus.

Dosage and Administration (34068-7)

Warnings and Precautions (34071-1)

Ask a doctor berfoe use if you have: Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema; Cough accompanied by excessive phlegm (mucus)

Section 50565-1 (50565-1)

Keep Out of Reach of Children: In case of overdose, get medical help or contact a Poison Control Center

Section 51727-6 (51727-6)

Silicon Dioxide, Magnesium Stearate, Maltodextrin, Cellulose, Microcrystalline, Povidone, Sodium Starch Glycolate, Stearic Acid

Section 55105-1 (55105-1)

PURPOSE: EXPECTORANT

Section 55106-9 (55106-9)

Each immediate release tablet contains: Guaifenesin 400 mg

How Supplied (HOW SUPPLIED)

Product: 50436-6232

NDC: 50436-6232-2 60 TABLET in a BOTTLE

Mucus Relief (guaifenesin) Tablet (MUCUS RELIEF (GUAIFENESIN) TABLET)

Advanced Ingredient Data

[{"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "400", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MALTODEXTRIN", "unii": "7CVR7L4A2D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE, UNSPECIFIED", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Helps loosen phlegm (mucus) and thin bronchial secretions to make coughts more productive to rid the bronchial passageway of bothersome mucus.", "34068-7": "Adults and children 12 years of age and older, take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours. Children under 12 years of age do not use", "34071-1": "Ask a doctor berfoe use if you have: Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema; Cough accompanied by excessive phlegm (mucus)", "50565-1": "Keep Out of Reach of Children: In case of overdose, get medical help or contact a Poison Control Center", "51727-6": "Silicon Dioxide, Magnesium Stearate, Maltodextrin, Cellulose, Microcrystalline, Povidone, Sodium Starch Glycolate, Stearic Acid", "55105-1": "PURPOSE: EXPECTORANT", "55106-9": "Each immediate release tablet contains: Guaifenesin 400 mg", "HOW SUPPLIED": "Product: 50436-6232 NDC: 50436-6232-2 60 TABLET in a BOTTLE"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:23.541107 · Updated: 2026-03-14T22:54:48.761962