Topcare Health Mucus Relief

SPL v3

SPL

SPL Set ID 03c17c06-6919-4ef4-9d0a-4c039940c671

Route

ORAL

Published

Effective Date 2025-12-03

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 Cellulose, Microcrystalline Povidone

Identifiers & Packaging

Pill Appearance

Imprint: G233 Shape: capsule Color: white Size: 22 mm Score: 1

Marketing Status

ANDA Active Since 2021-06-01

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

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 seal on bottle printed "SEALED for YOUR PROTECTION" is torn or missing
store between 20 to 25°C (68 to 77°F)

Inactive Ingredients

carbomer homopolymer, hypromellose, microcrystalline cellulose, povidone

Principal Display Panel

Topcare health

NDC 36800-226-16

COMPARE TO MUCINEX^® EXTENDED RELEASE TABLETS 600 mg - EXPECTORANT

Mucus Relief

GUAIFENESIN EXTENDED RELEASE TABLETS 600 mg - EXPECTORANT

Relieves Chest Congestion
Thins and Loosens Mucus

12 Hour

100 EXTENDED-RELEASE TABLETS

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 600 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)

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 seal on bottle printed "SEALED for YOUR PROTECTION" is torn 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)

Topcare health

NDC 36800-226-16

COMPARE TO MUCINEX^® EXTENDED RELEASE TABLETS 600 mg - EXPECTORANT

Mucus Relief

GUAIFENESIN EXTENDED RELEASE TABLETS 600 mg - EXPECTORANT

Relieves Chest Congestion
Thins and Loosens Mucus

12 Hour

100 EXTENDED-RELEASE TABLETS

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 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": "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": ".", "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 seal on bottle printed "SEALED for YOUR PROTECTION" is torn or missing store between 20 to 25°C (68 to 77°F)", "INACTIVE INGREDIENTS": "carbomer homopolymer, hypromellose, microcrystalline cellulose, povidone", "PRINCIPAL DISPLAY PANEL": "Topcare health NDC 36800-226-16 COMPARE TO MUCINEX ® EXTENDED RELEASE TABLETS 600 mg - EXPECTORANT Mucus Relief GUAIFENESIN EXTENDED RELEASE TABLETS 600 mg - EXPECTORANT Relieves Chest Congestion Thins and Loosens Mucus 12 Hour 100 EXTENDED-RELEASE TABLETS", "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 600 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:25.810157 · Updated: 2026-03-14T23:10:51.714911