Guifenisen 400 Mg

SPL v5

SPL

SPL Set ID ae469d4f-91c4-cff0-e053-2995a90a0497

Route

ORAL

Published

Effective Date 2020-08-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (400 mg)

Inactive Ingredients

Cellulose, Microcrystalline Povidone Magnesium Stearate Maltodextrin

Identifiers & Packaging

Pill Appearance

Imprint: A;152 Shape: oval Color: white Size: 17 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-08-01

Description

Guaifenesin 400 mg

Purpose

Expectorant

Medication Information

Purpose

Expectorant

Description

Guaifenesin 400 mg

Uses

helps lossen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersone mucus and make coughs more productive

Section 42229-5

Drug Facts continued on back of label

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

Distributed by: Reliable-1 Laboratoreis LLC

Valley Stream, Ny 11580 www.reliable1labs.com

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

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 a serious illness.

Section 51945-4

NDC 69618-061-06

Reliable-1 Laboratories

Guaifenesin 400 mg

Expectorant

60 CAPLETS

Section 53414-9

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

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 too much phlegm (mucus)

Stop use and ask a doctor if cough lasts more then 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signes of serious illness.

Directions

do not take more than 6 doses in any 24- hour period
this product is not intended for use in children under 12 years of age
adults & children 12 years and over: 1 caplet every 4 hours
children under 12 years: do not use

Other Information

store at 15°-30°C (59°-86°F)

Inactive Ingredients

colloidal silicon dioxide, magnesium stearate, maltodextrin, microsrystalline cellulose, providone, stearic acid

Questions Or Comments?

call 516-341-0666, 8:30 am-4:30 pm ET, Monday-Friday

Active Ingredient (in Each Caplet)

Guaifenesin 400 mg

Structured Label Content

Uses

helps lossen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersone mucus and make coughs more productive

Section 42229-5 (42229-5)

Drug Facts continued on back of label

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

Distributed by: Reliable-1 Laboratoreis LLC

Valley Stream, Ny 11580 www.reliable1labs.com

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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 a serious illness.

Section 51945-4 (51945-4)

NDC 69618-061-06

Reliable-1 Laboratories

Guaifenesin 400 mg

Expectorant

60 CAPLETS

Section 53414-9 (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 too much phlegm (mucus)

Stop use and ask a doctor if cough lasts more then 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signes of serious illness.

Directions

do not take more than 6 doses in any 24- hour period
this product is not intended for use in children under 12 years of age
adults & children 12 years and over: 1 caplet every 4 hours
children under 12 years: do not use

Other Information (Other information)

store at 15°-30°C (59°-86°F)

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, magnesium stearate, maltodextrin, microsrystalline cellulose, providone, stearic acid

Questions Or Comments? (Questions or comments?)

call 516-341-0666, 8:30 am-4:30 pm ET, Monday-Friday

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Guaifenesin 400 mg

Advanced Ingredient Data

[{"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "400", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "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": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "helps lossen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersone mucus and make coughs more productive", "42229-5": "Drug Facts continued on back of label TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Distributed by: Reliable-1 Laboratoreis LLC Valley Stream, Ny 11580 www.reliable1labs.com", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50566-9": "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 a serious illness.", "51945-4": "NDC 69618-061-06 Reliable-1 Laboratories Guaifenesin 400 mg Expectorant 60 CAPLETS", "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 too much phlegm (mucus) Stop use and ask a doctor if cough lasts more then 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signes of serious illness.", "Directions": "do not take more than 6 doses in any 24- hour period this product is not intended for use in children under 12 years of age adults & children 12 years and over: 1 caplet every 4 hours children under 12 years: do not use", "Other information": "store at 15°-30°C (59°-86°F)", "Inactive ingredients": "colloidal silicon dioxide, magnesium stearate, maltodextrin, microsrystalline cellulose, providone, stearic acid", "Questions or comments?": "call 516-341-0666, 8:30 am-4:30 pm ET, Monday-Friday", "Active ingredient (in each caplet)": "Guaifenesin 400 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:22.103393 · Updated: 2026-03-14T23:07:03.829205