Guifenisen 400 Mg

SPL v102

SPL

SPL Set ID 570a71eb-2d19-4c7b-8c00-e1524bfa3844

Route

ORAL

Published

Effective Date 2011-12-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (400 mg)

Inactive Ingredients

Microcrystalline Cellulose Povidone, Unspecified 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

How Supplied

Guaifenesin 400 mg NDC: 71335-9616-1: 30 Tablets in a BOTTLE, PLASTIC NDC: 71335-9616-2: 20 Tablets in a BOTTLE, PLASTIC NDC: 71335-9616-3: 50 Tablets in a BOTTLE, PLASTIC NDC: 71335-9616-4: 60 Tablets in a BOTTLE, PLASTIC NDC: 71335-9616-5: 40 Tablets in a BOTTLE, PLASTIC Store at 15°-30°C (59°-86°F) Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Medication Information

Purpose

Expectorant

How Supplied

Guaifenesin 400 mg

NDC: 71335-9616-1: 30 Tablets in a BOTTLE, PLASTIC

NDC: 71335-9616-2: 20 Tablets in a BOTTLE, PLASTIC

NDC: 71335-9616-3: 50 Tablets in a BOTTLE, PLASTIC

NDC: 71335-9616-4: 60 Tablets in a BOTTLE, PLASTIC

NDC: 71335-9616-5: 40 Tablets in a BOTTLE, PLASTIC

Store at 15°-30°C (59°-86°F)

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

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

Guaifenesin 400 mg Tablet

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)

Guaifenesin 400 mg Tablet

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

How Supplied (HOW SUPPLIED)

Guaifenesin 400 mg

NDC: 71335-9616-1: 30 Tablets in a BOTTLE, PLASTIC

NDC: 71335-9616-2: 20 Tablets in a BOTTLE, PLASTIC

NDC: 71335-9616-3: 50 Tablets in a BOTTLE, PLASTIC

NDC: 71335-9616-4: 60 Tablets in a BOTTLE, PLASTIC

NDC: 71335-9616-5: 40 Tablets in a BOTTLE, PLASTIC

Store at 15°-30°C (59°-86°F)

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

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": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE, UNSPECIFIED", "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": "Guaifenesin 400 mg Tablet", "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", "HOW SUPPLIED": "Guaifenesin 400 mg NDC: 71335-9616-1: 30 Tablets in a BOTTLE, PLASTIC NDC: 71335-9616-2: 20 Tablets in a BOTTLE, PLASTIC NDC: 71335-9616-3: 50 Tablets in a BOTTLE, PLASTIC NDC: 71335-9616-4: 60 Tablets in a BOTTLE, PLASTIC NDC: 71335-9616-5: 40 Tablets in a BOTTLE, PLASTIC Store at 15°-30°C (59°-86°F) Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504", "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: 2026-02-15T12:05:50.480708 · Updated: 2026-03-14T23:08:12.555949