370 - Health A2z Mucus Relief

SPL v5

SPL

SPL Set ID 221d64a2-b8c7-435a-aae4-fb58fd38108f

Route

ORAL

Published

Effective Date 2019-03-26

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: round Color: white Size: 17 mm Score: 2

Marketing Status

OTC MONOGRAPH DRUG Active Since 2014-12-23

Description

Guaifenesin 400mg

Purpose

Expectorant

Medication Information

Purpose

Expectorant

Description

Guaifenesin 400mg

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive to rid the bronchial passageway of bothersome mucus

Directions

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

Active Ingredient

Guaifenesin 400mg

Other Information

store at 25°C (77°F) excursions between 15°-30°C (59°-86°F)
keep in a dry place and do not expose to heat
do not use if imprinted safety seal under cap is broken or missing

Inactive Ingredients

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

Questions Or Comments?

Call 1-888-952-0050

Monday through Friday 9AM - PM EST.

Pregnancy/breastfeeding

ask a health 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

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.

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)

Structured Label Content

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive to rid the bronchial passageway of bothersome mucus

Purpose

Expectorant

Directions

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

Active Ingredient (Active ingredient)

Guaifenesin 400mg

Other Information (Other information)

store at 25°C (77°F) excursions between 15°-30°C (59°-86°F)
keep in a dry place and do not expose to heat
do not use if imprinted safety seal under cap is broken or missing

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

Call 1-888-952-0050

Monday through Friday 9AM - PM EST.

Pregnancy/breastfeeding (Pregnancy/Breastfeeding)

ask a health 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

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.

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 excessive phlegm (mucus)

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)

{"Uses": "helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive to rid the bronchial passageway of bothersome mucus", "Purpose": "Expectorant", "Directions": "Adults and children 12 years of age and older: t ake 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", "Active ingredient": "Guaifenesin 400mg", "Other information": "store at 25°C (77°F) excursions between 15°-30°C (59°-86°F) keep in a dry place and do not expose to heat do not use if imprinted safety seal under cap is broken or missing", "Inactive ingredients": "Croscarmellose Sodium, Maltodextrin, Microcrystalline Cellulose, Povidone, Silicon Dioxide, Stearic Acid", "Questions or comments?": "Call 1-888-952-0050 Monday through Friday 9AM - PM EST.", "Pregnancy/Breastfeeding": "ask a health 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", "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.", "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)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:16.608610 · Updated: 2026-03-14T23:01:41.296752