Guaifenesin Extended-release Tablets, 600 Mg

SPL v3

SPL

SPL Set ID d1ffd899-2a2a-41c0-b0c0-7c42f8cabf8d

Route

ORAL

Published

Effective Date 2022-04-29

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (600 mg)

Inactive Ingredients

Hypromellose, Unspecified Magnesium Stearate Silicon Dioxide Fd&c Blue No. 2 Povidone, Unspecified

Identifiers & Packaging

Pill Appearance

Imprint: RH98 Shape: oval Color: white Size: 16 mm Score: 1

Marketing Status

ANDA Active Since 2022-04-28

Description

Drug Facts

Purpose

Expectorant

Medication Information

Purpose

Expectorant

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

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

Section 53414-9

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

Directions

do not crush, chew, or break extended-release 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: one or two extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours.
children under 12 years of age: do not use

Do Not Use

for children under 12 years of age

Other Information

store between 20-25°C (68-77°F)
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPEN OR IF PRINTED SEAL ON BLISTER IS BROKEN OR MISSING.

Inactive Ingredients

colloidal silicon dioxide, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, povidone.

Stop Use and Ask A Doctor If

cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.

These could be signs of a serious illness.

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)

Active Ingredient (in Each Extended Release Tablet)

Guaifenesin USP 600 mg

Principal Display Panel 20 Tablets Blister Pack Carton

COMPARE TO the active ingredient of

Mucinex^®

NDC 30142-961-20

Kroger_®

OUR PHARMACIST RECOMMENDED

Mucus

Relief ER

Guaifenesin 600 mg

Extended-Release

Tablets,

EXPECTORANT

12 HOUR

Relieves Chest Congestion
Thins & Loosens Mucus

20 EXTENDED-RELEASE

TABLETS

Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

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 (1-800-222-1222).

Section 53414-9 (53414-9)

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

Purpose

Expectorant

Directions

do not crush, chew, or break extended-release 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: one or two extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours.
children under 12 years of age: do not use

Do Not Use (Do not use)

for children under 12 years of age

Other Information (Other information)

store between 20-25°C (68-77°F)
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPEN OR IF PRINTED SEAL ON BLISTER IS BROKEN OR MISSING.

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, povidone.

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

cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.

These could be signs of a serious illness.

Ask A Doctor Before Use If You Have (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)

Active Ingredient (in Each Extended Release Tablet) (Active ingredient (in each extended-release tablet))

Guaifenesin USP 600 mg

Principal Display Panel 20 Tablets Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 20 Tablets Blister Pack Carton)

COMPARE TO the active ingredient of

Mucinex^®

NDC 30142-961-20

Kroger_®

OUR PHARMACIST RECOMMENDED

Mucus

Relief ER

Guaifenesin 600 mg

Extended-Release

Tablets,

EXPECTORANT

12 HOUR

Relieves Chest Congestion
Thins & Loosens Mucus

20 EXTENDED-RELEASE

TABLETS

Advanced Ingredient Data

[{"name": "Guaifenesin", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "600", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 2", "unii": "L06K8R7DQK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE, UNSPECIFIED", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Expectorant", "Directions": "do not crush, chew, or break extended-release 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: one or two extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours. children under 12 years of age: do not use", "Do not use": "for children under 12 years of age", "Other information": "store between 20-25°C (68-77°F) TAMPER EVIDENT: DO NOT USE IF CARTON IS OPEN OR IF PRINTED SEAL ON BLISTER IS BROKEN OR MISSING.", "Inactive ingredients": "colloidal silicon dioxide, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, povidone.", "Stop use and ask a doctor if": "cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.", "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)", "Active ingredient (in each extended-release tablet)": "Guaifenesin USP 600 mg", "PRINCIPAL DISPLAY PANEL - 20 Tablets Blister Pack Carton": "COMPARE TO the active ingredient of Mucinex ® NDC 30142-961-20 Kroger ® OUR PHARMACIST RECOMMENDED Mucus Relief ER Guaifenesin 600 mg Extended-Release Tablets, EXPECTORANT 12 HOUR Relieves Chest Congestion Thins & Loosens Mucus 20 EXTENDED-RELEASE TABLETS"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:12.369611 · Updated: 2026-03-14T23:00:34.965652