Guaifenesin Caplets, 400 Mg

SPL v2

SPL

SPL Set ID 5b78bbe9-806c-443f-bc23-351e5342355f

Route

ORAL

Published

Effective Date 2017-10-25

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 Maltodextrin Povidone Stearic Acid

Identifiers & Packaging

Pill Appearance

Imprint: AP;152 Shape: oval Color: white Size: 17 mm Score: 2

Marketing Status

OTC MONOGRAPH FINAL Active Since 2016-11-01

Description

Guaifenesin 400 mg

Purpose

Expectorant

Medication Information

Purpose

Expectorant

Description

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 and make cough more productive

Section 60561-8

store at 15°-30°C (59°-86°F)
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

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

Inactive Ingredients

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

Questions Or Comments

call 631-981-4600, 8.30 am-4.30 pm ET, Monday - Friday

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Principal Display Panel

Guaifenesin 400 mg... Expectorant

NDC-17714-152-01 100 tabs

Stop Use and Ask A Doctor

if cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache.These could be signs of serious illness

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

In Case of Pregnancy Or Breast Feeding Section

ask a health professional before use

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 and make cough more productive

Section 60561-8 (60561-8)

store at 15°-30°C (59°-86°F)
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

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

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments (Questions or Comments)

call 631-981-4600, 8.30 am-4.30 pm ET, Monday - Friday

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Principal Display Panel

Guaifenesin 400 mg... Expectorant

NDC-17714-152-01 100 tabs

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

if cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache.These could be signs of serious illness

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.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Guaifenesin 400 mg

In Case of Pregnancy Or Breast Feeding Section (IN CASE OF PREGNANCY OR BREAST FEEDING SECTION)

ask a health professional before use

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": "MALTODEXTRIN", "unii": "7CVR7L4A2D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "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 and make cough more productive", "60561-8": "store at 15°-30°C (59°-86°F) TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING", "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", "Inactive ingredients": "colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, stearic acid, sodium starch glycolate", "Questions or Comments": "call 631-981-4600, 8.30 am-4.30 pm ET, Monday - Friday TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING", "Principal Display Panel": "Guaifenesin 400 mg... Expectorant NDC-17714-152-01 100 tabs", "stop use and ask a doctor": "if cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache.These could be signs of serious illness", "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", "IN CASE OF PREGNANCY OR BREAST FEEDING SECTION": "ask a health professional before use"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:26.118826 · Updated: 2026-03-14T22:54:54.026912