Package Label

Package Label
SPL v5
SPL
SPL Set ID b091ace8-72ab-426a-bba6-97787805f63e
Route
ORAL
Published
Effective Date 2025-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Guaifenesin 600 mg


Medication Information

Indications and Usage

Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes coughs more productive.

Dosage and Administration

do not crush, chew, or break tablet take with a full glass of water this product can be administered without regard for the timing of meals adults and children 12 years of age and over: 1 or 2 tablet every 12 hours. Do not exceed 4 tablets in 24 hours. children under 12 years of age: do not use 

Description

Guaifenesin 600 mg

Section 44425-7

store between 20º to 25ºC (68º to 77ºF)

Section 50565-1

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 50566-9

cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious illness.

Section 50569-3

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

Section 50570-1

for children under 12 years of age.

Section 51727-6

carbomer, colloidal silicon dioxide, FD & C blue #1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, talc

Section 51945-4

Compare to the active ingredient in Mucinex®* MUCUS RELIEF GUAIFENESIN 600 MG EXPECTORANT Temporarily relieves chest congestion Thins & loosen mucus 12 HOUR EXTENDED-RELEASE TABLETS *This product is not manufactured or distributed by Reckitt Benckiser LLC, distributor of Mucinex®. TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL, PA 17011 www.riteaid.com

Section 53413-1

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Section 53414-9

ask a health professional before use.

Section 55105-1

Expectorant

Section 55106-9

Guaifenesin 600 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 makes coughs more productive.

Dosage and Administration (34068-7)

do not crush, chew, or break tablet take with a full glass of water this product can be administered without regard for the timing of meals adults and children 12 years of age and over: 1 or 2 tablet every 12 hours. Do not exceed 4 tablets in 24 hours. children under 12 years of age: do not use 

Section 44425-7 (44425-7)

store between 20º to 25ºC (68º to 77ºF)

Section 50565-1 (50565-1)

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 50566-9 (50566-9)

cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious illness.

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

for children under 12 years of age.

Section 51727-6 (51727-6)

carbomer, colloidal silicon dioxide, FD & C blue #1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, talc

Section 51945-4 (51945-4)

Compare to the active ingredient in Mucinex®* MUCUS RELIEF GUAIFENESIN 600 MG EXPECTORANT Temporarily relieves chest congestion Thins & loosen mucus 12 HOUR EXTENDED-RELEASE TABLETS *This product is not manufactured or distributed by Reckitt Benckiser LLC, distributor of Mucinex®. TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL, PA 17011 www.riteaid.com

Section 53413-1 (53413-1)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Section 53414-9 (53414-9)

ask a health professional before use.

Section 55105-1 (55105-1)

Expectorant

Section 55106-9 (55106-9)

Guaifenesin 600 mg


Raw Label Data

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