370- Mucus Relief

SPL v7

SPL

SPL Set ID 7d91c6ab-d161-42b9-b353-0aa8f59619f8

Route

ORAL

Published

Effective Date 2021-01-21

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (400 mg)

Inactive Ingredients

Croscarmellose Sodium Microcrystalline Cellulose Silicon Dioxide Stearic Acid Povidone Maltodextrin

Identifiers & Packaging

Pill Appearance

Shape: oval Color: white Size: 17 mm Score: 2

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2014-12-23 Until 2022-01-31

Description

Guaifenesin 400 mg

Purpose

Expectorant

Medication Information

Purpose

Expectorant

Description

Guaifenesin 400 mg

Use(s)

helps loosen phlegm (mucus)and thin bronchial secretions to make

coughs more productive to rid the bronchial passageway of bothersome mucus

Storage

store at 25°C (77°F) excursions between 15° to 30°C (59° to 86°F)

keep in a dry place and do not expose to heat

Questions

Call 1-888-423-0139

Directions

Adults and children12 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 under12 years of age: do not use

Other Information

do not use if imprinted safety seal under cap is broken or missing

Active Ingredient(s)

Guaifenesin 400 mg

Inactive Ingredients

Croscarmellose Sodium, Maltodextrin, Microcrystalline Cellulose, Povidone, Silicon Dioxide, Stearic Acid

Pregnancy/breastfeeding

ask a healthcare professional before use.

Principal Display Panel

Mucus Relief

When Using This Product

do not exceed recommended dosage
do not use for more than 7 days

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 excessive phlegm (mucus)

Stop Use and Ask A Doctor If

cough lasts for more than 7 days, recurs, or is

accompanied by fever, rash, or persistent

headache. These could be signs of a

serious condition.

Keep Out of Reach of Children

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Structured Label Content

Use(s)

helps loosen phlegm (mucus)and thin bronchial secretions to make

coughs more productive to rid the bronchial passageway of bothersome mucus

Purpose

Expectorant

Storage

store at 25°C (77°F) excursions between 15° to 30°C (59° to 86°F)

keep in a dry place and do not expose to heat

Questions

Call 1-888-423-0139

Directions

Adults and children12 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 under12 years of age: do not use

Other Information (Other information)

do not use if imprinted safety seal under cap is broken or missing

Active Ingredient(s) (Active ingredient(s))

Guaifenesin 400 mg

Inactive Ingredients (Inactive ingredients)

Croscarmellose Sodium, Maltodextrin, Microcrystalline Cellulose, Povidone, Silicon Dioxide, Stearic Acid

Pregnancy/breastfeeding (Pregnancy/Breastfeeding)

ask a healthcare professional before use.

Principal Display Panel

Mucus Relief

When Using This Product (When using this product)

do not exceed recommended dosage
do not use for more than 7 days

Ask A Doctor Before Use If (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 excessive phlegm (mucus)

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

cough lasts for more than 7 days, recurs, or is

accompanied by fever, rash, or persistent

headache. These could be signs of a

serious condition.

Keep Out of Reach of Children (Keep out of reach of children)

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Advanced Ingredient Data

[{"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "400", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MALTODEXTRIN", "unii": "7CVR7L4A2D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use(s)": "helps loosen phlegm (mucus)and thin bronchial secretions to make coughs more productive to rid the bronchial passageway of bothersome mucus", "Purpose": "Expectorant", "Storage": " store at 25°C (77°F) excursions between 15° to 30°C (59° to 86°F) keep in a dry place and do not expose to heat", "Questions": "Call 1-888-423-0139", "Directions": "Adults and children12 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 under12 years of age: do not use", "Other information": "do not use if imprinted safety seal under cap is broken or missing", "Active ingredient(s)": "Guaifenesin 400 mg", "Inactive ingredients": "Croscarmellose Sodium, Maltodextrin, Microcrystalline Cellulose, Povidone, Silicon Dioxide, Stearic Acid", "Pregnancy/Breastfeeding": "ask a healthcare professional before use.", "Principal Display Panel": "Mucus Relief", "When using this product": "do not exceed recommended dosage do not use for more than 7 days", "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 excessive phlegm (mucus)", "Stop use and ask a doctor if": "cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.", "Keep out of reach of children": "In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:16.661314 · Updated: 2026-03-14T23:01:42.949822