Guaifenesin Extended Release Tablets 600 Mg And 1200 Mg

SPL v2

SPL

SPL Set ID 20f9e083-419d-429d-a570-24b312ed5d2a

Route

ORAL

Published

Effective Date 2018-02-28

Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (600 mg)

Inactive Ingredients

Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked) Hypromellose 2208 (100000 Mpa.s) Cellulose, Microcrystalline Povidone

Identifiers & Packaging

Pill Appearance

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

Marketing Status

ANDA Active Since 2018-03-01

Description

Guaifenesin 600 mg

Purpose

Expectorant

Medication Information

Purpose

Expectorant

Description

Guaifenesin 600 mg

Use(s)

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

Warning

Warnings

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 or 2 tablets every 12 hours.
Do not exceed 4 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

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.

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).

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.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Principal Display Panel 600 Mg

NDC 53041-233-32

GUARDIAN

12 HOUR

Guaifenesin

Extended-Release

Tablets 600 mg

Expectorant

Relieves Chest Congestion

Thins and Loosens Mucus

20 EXTENDED-RELEASE TABLETS

Principal Display Panel 1200 Mg

NDC 53041-234-58

GUARDIAN

12 HOUR

MAXIMUM STRENGTH

Guaifenesin

Extended-Release

Tablets 1200 mg

Expectorant

Relieves Chest Congestion

Thins and Loosens Mucuc

14 EXTENDED-RELEASE TABLETS

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 600 mg

Active Ingredient (in Each Extended Release Tablet)

Guaifenesin 1200 mg

Structured Label Content

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

Purpose (PURPOSE)

Expectorant

Warning (WARNING)

Warnings (WARNINGS)

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 or 2 tablets every 12 hours.
Do not exceed 4 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

Questions? (QUESTIONS?)

1-609-860-2600

Hours: 8am - 4pm, EST

You may also report side effects to this phone number.

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

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.

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).

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.

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

ask a health professional before use.

Principal Display Panel 600 Mg (PRINCIPAL DISPLAY PANEL 600 MG)

NDC 53041-233-32

GUARDIAN

12 HOUR

Guaifenesin

Extended-Release

Tablets 600 mg

Expectorant

Relieves Chest Congestion

Thins and Loosens Mucus

20 EXTENDED-RELEASE TABLETS

Principal Display Panel 1200 Mg (PRINCIPAL DISPLAY PANEL 1200 MG)

NDC 53041-234-58

GUARDIAN

12 HOUR

MAXIMUM STRENGTH

Guaifenesin

Extended-Release

Tablets 1200 mg

Expectorant

Relieves Chest Congestion

Thins and Loosens Mucuc

14 EXTENDED-RELEASE TABLETS

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 600 mg

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

Guaifenesin 1200 mg

Advanced Ingredient Data

[{"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "600", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)", "unii": "HHT01ZNK31", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE 2208 (100000 MPA.S)", "unii": "VM7F0B23ZI", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "1200", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)", "unii": "HHT01ZNK31", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE 2208 (100000 MPA.S)", "unii": "VM7F0B23ZI", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "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": ".", "WARNINGS": ".", "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 or 2 tablets every 12 hours. Do not exceed 4 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", "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. ", "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).", "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.", "IF PREGNANT OR BREAST-FEEDING,": "ask a health professional before use. ", "PRINCIPAL DISPLAY PANEL 600 MG": "NDC 53041-233-32 GUARDIAN 12 HOUR Guaifenesin Extended-Release Tablets 600 mg Expectorant Relieves Chest Congestion Thins and Loosens Mucus 20 EXTENDED-RELEASE TABLETS", "PRINCIPAL DISPLAY PANEL 1200 MG": "NDC 53041-234-58 GUARDIAN 12 HOUR MAXIMUM STRENGTH Guaifenesin Extended-Release Tablets 1200 mg Expectorant Relieves Chest Congestion Thins and Loosens Mucuc 14 EXTENDED-RELEASE TABLETS", "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 600 mg", "ACTIVE INGREDIENT (in each extended-release tablet)": "Guaifenesin 1200 mg "}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:31.549255 · Updated: 2026-03-14T22:55:03.293878