Principal Display Panel

Principal Display Panel
SPL v5
SPL
SPL Set ID b2e88323-5af9-4ec8-bb98-4da0a774e54e
Route
ORAL
Published
Effective Date 2025-07-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Guaifenesin 400 mg


Medication Information

Indications and Usage

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

Dosage and Administration

take with a full glass of water adults and children 12 years and over: 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours. children under 12 years: do not use

Description

Guaifenesin 400 mg

Section 44425-7

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number

Section 50565-1

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

Section 50566-9

cough persists more than 7 days, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition.

Section 50569-3

cough accompanied by too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Section 51727-6

FD & C blue #1 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid

Section 51945-4

Premier  Value ® Immediate release Mucus Relief GUAIFENESIN, 400 mg Expectorant Relieves Chest Congestion Thins and Loosens Mucus actual size 50 Tablets PV INDEPENDENTLY TESTED SATISFACTION GUARANTEED TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING 50844 ORG011853215 Distributed By: Pharmacy Value Alliance, LLC 407 East Lancaster Avenue, Wayne, PA 19087 PV INDEPENDENTLY TESTED SATISFACTION GUARANTEED If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund. Premier Value 44-532

Section 53413-1

1-800-426-9391

Section 53414-9

ask a health professional before use.

Section 55105-1

Expectorant

Section 55106-9

Guaifenesin 400 mg


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

take with a full glass of water adults and children 12 years and over: 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours. children under 12 years: do not use

Section 44425-7 (44425-7)

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

cough persists more than 7 days, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition.

Section 50569-3 (50569-3)

cough accompanied by too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Section 51727-6 (51727-6)

FD & C blue #1 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid

Section 51945-4 (51945-4)

Premier  Value ® Immediate release Mucus Relief GUAIFENESIN, 400 mg Expectorant Relieves Chest Congestion Thins and Loosens Mucus actual size 50 Tablets PV INDEPENDENTLY TESTED SATISFACTION GUARANTEED TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING 50844 ORG011853215 Distributed By: Pharmacy Value Alliance, LLC 407 East Lancaster Avenue, Wayne, PA 19087 PV INDEPENDENTLY TESTED SATISFACTION GUARANTEED If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund. Premier Value 44-532

Section 53413-1 (53413-1)

1-800-426-9391

Section 53414-9 (53414-9)

ask a health professional before use.

Section 55105-1 (55105-1)

Expectorant

Section 55106-9 (55106-9)

Guaifenesin 400 mg


Raw Label Data

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