Cvs Pharmacy, Inc. Mucus Extended-release Drug Facts

SPL v2

SPL

SPL Set ID 9fcf96a7-bef4-4cc8-bd9e-c245ccbea17d

Route

ORAL

Published

Effective Date 2025-06-17

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (1200 mg)

Inactive Ingredients

Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked) Copovidone K25-31 Fd&c Blue No. 1 Aluminum Lake Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Silicon Dioxide Sodium Starch Glycolate Type A

Identifiers & Packaging

Pill Appearance

Imprint: L4S1 Shape: oval Color: blue Size: 22 mm Score: 1

Marketing Status

ANDA Active Since 2025-06-17

Description

Guaifenesin 1200 mg

Purpose

Expectorant

Medication Information

Purpose

Expectorant

Description

Guaifenesin 1200 mg

Uses

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

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 timing of meals
•
adults and children 12 years of age and over: 1 extended-release tablet every 12 hours. Do not exceed 2 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 at 20-25°C (68-77°F)

Inactive Ingredients

carbomer homopolymer type B, copovidone, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium starch glycolate

Questions Or Comments?

1-800-719-9260

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.

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).

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)

Package/label Principal Display Panel

CVS Health_®

Compare to the active ingredient in Maximum Strength Mucinex^®

MAXIMUM STRENGTH

Mucus Extended-Release

12 HOUR

GUAIFENESIN EXTENDED-RELEASE TABLETS, 1200 mg

EXPECTORANT

• Relieves chest congestion

• Thins & loosens mucus

• Immediate & extended-release

Actual Size

42 EXTENDED-RELEASE TABLETS

Active Ingredient (in Each Extended Release Tablet)

Guaifenesin 1200 mg

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

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 timing of meals
•
adults and children 12 years of age and over: 1 extended-release tablet every 12 hours. Do not exceed 2 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 at 20-25°C (68-77°F)

Inactive Ingredients (Inactive ingredients)

carbomer homopolymer type B, copovidone, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium starch glycolate

Questions Or Comments? (Questions or comments?)

1-800-719-9260

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.

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).

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)

Package/label Principal Display Panel (Package/Label Principal Display Panel)

CVS Health_®

Compare to the active ingredient in Maximum Strength Mucinex^®

MAXIMUM STRENGTH

Mucus Extended-Release

12 HOUR

GUAIFENESIN EXTENDED-RELEASE TABLETS, 1200 mg

EXPECTORANT

• Relieves chest congestion

• Thins & loosens mucus

• Immediate & extended-release

Actual Size

42 EXTENDED-RELEASE TABLETS

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": "1200", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)", "unii": "HHT01ZNK31", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COPOVIDONE K25-31", "unii": "D9C330MD8B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1 ALUMINUM LAKE", "unii": "J9EQA3S2JM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A", "unii": "H8AV0SQX4D", "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", "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 timing of meals • adults and children 12 years of age and over: 1 extended-release tablet every 12 hours. Do not exceed 2 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 at 20-25°C (68-77°F)", "Inactive ingredients": "carbomer homopolymer type B, copovidone, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium starch glycolate", "Questions or comments?": "1-800-719-9260", "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.", "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).", "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)", "Package/Label Principal Display Panel": "CVS Health ® Compare to the active ingredient in Maximum Strength Mucinex ® MAXIMUM STRENGTH Mucus Extended-Release 12 HOUR GUAIFENESIN EXTENDED-RELEASE TABLETS, 1200 mg EXPECTORANT • Relieves chest congestion • Thins & loosens mucus • Immediate & extended-release Actual Size 42 EXTENDED-RELEASE TABLETS", "Active ingredient (in each extended-release tablet)": "Guaifenesin 1200 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:20.941563 · Updated: 2026-03-14T23:09:05.302478