valumeds mucus relief caplets guaifenesin 400mg

SPL v2

SPL

SPL Set ID 26a51b0e-039c-663c-e063-6394a90ad384

Route

oral

Published

Effective Date 2017-06-05

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

guaifenesin (400 mg)

Inactive Ingredients

silicon dioxide magnesium stearate cellulose, microcrystalline stearic acid povidone maltodextrin croscarmellose sodium

Identifiers & Packaging

Pill Appearance

Imprint: S400 Shape: oval Color: white Size: 17 mm Score: 1

Marketing Status

otc monograph drug active Since 2024-11-01

Purpose

Expectorant

Description

Guaifenesin 400 mg

Medication Information

Warnings

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)

Active Ingredient

Guaifenesin 400 mg

Uses

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

Purpose

Expectorant

Other Information

each tablet contains: sodium 1.24 mg VERY LOW SODIUM
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
read all product information before using
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive Ingredients

colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, stearic acid, sodium starch glycolate

Description

Guaifenesin 400 mg

Principal Display Panel

ValuMeds Mucus Relief Caplets Guaifenesin 400mg (200 Caplets) | Chest Congestion and Decongestant | Thins and Loosens Buildup | Fast Acting

NDC 82725-1012-1

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

Directions:

adults and children 12 years of age and over: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:do not use

Questions Or Comments

contact 1-908-242-6108 Mon- Fri 8:00 AM EST to 5:00 PM

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 overdose, get medical help or contact a Poison Control Center right away.

Structured Label Content

Warnings

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)

Active Ingredient (Active ingredient (in each tablet))

Guaifenesin 400 mg

Uses

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

Purpose

Expectorant

Other Information (Other information)

each tablet contains: sodium 1.24 mg VERY LOW SODIUM
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
read all product information before using
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, stearic acid, sodium starch glycolate

Principal Display Panel

ValuMeds Mucus Relief Caplets Guaifenesin 400mg (200 Caplets) | Chest Congestion and Decongestant | Thins and Loosens Buildup | Fast Acting

NDC 82725-1012-1

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Directions:

adults and children 12 years of age and over: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:do not use

Questions Or Comments (Questions or Comments)

contact 1-908-242-6108 Mon- Fri 8:00 AM EST to 5:00 PM

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 overdose, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

[{"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "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": "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": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "400", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

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", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Expectorant", "Warnings": "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)", "Directions:": "adults and children 12 years of age and over: 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: do not use", "Other information": "each tablet contains: sodium 1.24 mg VERY LOW SODIUM 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 read all product information before using TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING", "Inactive ingredients": "colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, stearic acid, sodium starch glycolate", "Questions or Comments": "contact 1-908-242-6108 Mon- Fri 8:00 AM EST to 5:00 PM", "Principal Display Panel": "ValuMeds Mucus Relief Caplets Guaifenesin 400mg (200 Caplets) | Chest Congestion and Decongestant | Thins and Loosens Buildup | Fast Acting NDC 82725-1012-1", "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 overdose, get medical help or contact a Poison Control Center right away.", "Active ingredient (in each tablet)": "Guaifenesin 400 mg"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:06:40.736581 · Updated: 2026-03-14T23:09:34.496634