mucus relief guaifenesin extended-release tablets 600 mg and 1200 mg

SPL v5

SPL

SPL Set ID e7742a43-9066-4e28-a90d-f07c0e18f045

Route

oral

Published

Effective Date 2022-01-13

Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients

guaifenesin (600 mg)

Inactive Ingredients

carbomer homopolymer, unspecified type hypromellose, unspecified microcrystalline cellulose povidone k90

Identifiers & Packaging

Pill Appearance

Imprint: G234 Shape: capsule Color: white Size: 17 mm Size: 22 mm Score: 1

Marketing Status

anda active Since 2020-06-24

Purpose

Expectorant

Description

Guaifenesin 1200 mg

Medication Information

Purpose

Expectorant

Directions

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 tablet every 12 hours.
Do not exceed 2 tablets in 24 hours.
children under 12 years of age: do not use

Other Information

tamper evident: do not use if carton is open or if printed seal on blister is broken or missing
store between 20 to 25°C (68 to 77°F)

Inactive Ingredients

carbomer homopolymer, hypromellose, microcrystalline cellulose, povidone

Description

Guaifenesin 1200 mg

Principal Display Panel

NDC 53041-191-58

Compare to the active ingredient in Mucinex® Maximum Strength Extended Release 1200 mg Tablets

GUARDIAN

12 HOUR

MAXIMUM STRENGTH

Mucus Relief

Guaifenesin Extended-Release Tablets 1200 mg

Expectorant

Relieves Chest Congestion

Thins and Loosens Mucus

14 EXTENDED-RELEASE TABLETS

NDC 53041-191-48

GUARDIAN

12 HOUR

MAXIMUM STRENGTH

Mucus Relief

Guaifenesin Extended-Release Tablets 1200 mg

Expectorant

Relieves Chest Congestion

Thins and Loosens Mucus

28 EXTENDED-RELEASE TABLETS

Questions?

1-609-860-2600

Hours: 8am - 4pm, EST

You may also report side effects to this phone number.

Use(s)

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

Warning

Questions

1-609-860-2600

Hours: 8am - 4pm, EST

You may also report side effects to this phone number.

Do Not Use

for children under 12 years of age

Stop Use and A Ask 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.

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.

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).

If Pregnant Or Breast Feeding,

ask a health professional before use.

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 1200 mg

Active Ingredient (in Each Extended Release Tablet)

Guaifenesin 600 mg

Structured Label Content

Purpose (PURPOSE)

Expectorant

Directions (DIRECTIONS)

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 tablet every 12 hours.
Do not exceed 2 tablets in 24 hours.
children under 12 years of age: do not use

Other Information (OTHER INFORMATION)

tamper evident: do not use if carton is open or if printed seal on blister is broken or missing
store between 20 to 25°C (68 to 77°F)

Inactive Ingredients (INACTIVE INGREDIENTS)

carbomer homopolymer, hypromellose, microcrystalline cellulose, povidone

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 53041-191-58

Compare to the active ingredient in Mucinex® Maximum Strength Extended Release 1200 mg Tablets

GUARDIAN

12 HOUR

MAXIMUM STRENGTH

Mucus Relief

Guaifenesin Extended-Release Tablets 1200 mg

Expectorant

Relieves Chest Congestion

Thins and Loosens Mucus

14 EXTENDED-RELEASE TABLETS

NDC 53041-191-48

GUARDIAN

12 HOUR

MAXIMUM STRENGTH

Mucus Relief

Guaifenesin Extended-Release Tablets 1200 mg

Expectorant

Relieves Chest Congestion

Thins and Loosens Mucus

28 EXTENDED-RELEASE TABLETS

Questions? (QUESTIONS?)

1-609-860-2600

Hours: 8am - 4pm, EST

You may also report side effects to this phone number.

Use(s) (USE(S))

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

Warning (WARNING)

Questions (QUESTIONS)

1-609-860-2600

Hours: 8am - 4pm, EST

You may also report side effects to this phone number.

Do Not Use (DO NOT USE)

for children under 12 years of age

Stop Use and A Ask Doctor If (STOP USE AND A ASK 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.

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.

Keep Out of Reach of Children (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).

If Pregnant Or Breast Feeding, (IF PREGNANT OR BREAST-FEEDING,)

ask a health professional before use.

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 1200 mg

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

Guaifenesin 600 mg

Advanced Ingredient Data

[{"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "600", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE K90", "unii": "RDH86HJV5Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "1200", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE K90", "unii": "RDH86HJV5Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USE(S)": "helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive", "PURPOSE": "Expectorant", "WARNING": ".", "QUESTIONS": "1-609-860-2600 Hours: 8am - 4pm, EST You may also report side effects to this phone number. ", "DIRECTIONS": "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 tablet every 12 hours. Do not exceed 2 tablets in 24 hours. children under 12 years of age: do not use", "DO NOT USE": "for children under 12 years of age", "QUESTIONS?": "1-609-860-2600 Hours: 8am - 4pm, EST You may also report side effects to this phone number. ", "OTHER INFORMATION": "tamper evident: do not use if carton is open or if printed seal on blister is broken or missing store between 20 to 25°C (68 to 77°F)", "INACTIVE INGREDIENTS": "carbomer homopolymer, hypromellose, microcrystalline cellulose, povidone", "PRINCIPAL DISPLAY PANEL": "NDC 53041-191-58 Compare to the active ingredient in Mucinex® Maximum Strength Extended Release 1200 mg Tablets GUARDIAN 12 HOUR MAXIMUM STRENGTH Mucus Relief Guaifenesin Extended-Release Tablets 1200 mg Expectorant Relieves Chest Congestion Thins and Loosens Mucus 14 EXTENDED-RELEASE TABLETS NDC 53041-191-48 GUARDIAN 12 HOUR MAXIMUM STRENGTH Mucus Relief Guaifenesin Extended-Release Tablets 1200 mg Expectorant Relieves Chest Congestion Thins and Loosens Mucus 28 EXTENDED-RELEASE TABLETS", "STOP USE AND A ASK 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.", "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.", "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).", "IF PREGNANT OR BREAST-FEEDING,": "ask a health professional before use.", "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 1200 mg", "ACTIVE INGREDIENT (in each extended- release tablet)": "Guaifenesin 600 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:02.569761 · Updated: 2026-03-14T23:02:53.135799