Guaifenesin Extended-release Tablets 600mg And 1200mg

SPL v6

SPL

SPL Set ID ba7c1e26-b7d0-4aea-e053-2a95a90a903e

Route

ORAL

Published

Effective Date 2020-07-09

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (1200 mg)

Inactive Ingredients

Carbomer Homopolymer Type B (allyl Sucrose Crosslinked) Hypromellose 2910 (5 Mpa.s) Sodium Starch Glycolate Type A Magnesium Stearate Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance

Imprint: G;600 Shape: oval Color: white Size: 22 mm Size: 16 mm Score: 1

Marketing Status

ANDA Active Since 2021-02-01

Description

Guaifenesin 600 mg (for 600mg) Guaifenesin 1200 mg (for 1200 mg)

Purpose

Expectorant

Medication Information

Purpose

Expectorant

Description

Guaifenesin 600 mg (for 600mg) Guaifenesin 1200 mg (for 1200 mg)

Use(s)

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

Warnings

Do not use

for children under 12 years of age

Directions

do not crush, chew, or break 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 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours(For 600mg)
adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.(For 1200mg)
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 20-25°C (68-77°F)

Active Ingredient(s)

Guaifenesin 600 mg (for 600mg)

Guaifenesin 1200 mg (for 1200 mg)

Inactive Ingredients

carbomer homopolymer type B; hypromellos, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions Or Comments

Contact 1-877-770-3183

Mon-Fri 8:00 AM EST to 5:00 PM PST.

All trademarks are property of their respective owners.MUCINEX is the registered trademark of Reckitt Benckiser LLC.

Pregnancy/breastfeeding

ask a health professional before use.

Principal Display Panel

Stop Use and 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)

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)

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

Warnings (WARNINGS)

Do not use

for children under 12 years of age

Directions (DIRECTIONS)

do not crush, chew, or break 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 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours(For 600mg)
adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.(For 1200mg)
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 20-25°C (68-77°F)

Active Ingredient(s) (ACTIVE INGREDIENT(S))

Guaifenesin 600 mg (for 600mg)

Guaifenesin 1200 mg (for 1200 mg)

Inactive Ingredients (INACTIVE INGREDIENTS)

carbomer homopolymer type B; hypromellos, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions Or Comments (QUESTIONS OR COMMENTS)

Contact 1-877-770-3183

Mon-Fri 8:00 AM EST to 5:00 PM PST.

All trademarks are property of their respective owners.MUCINEX is the registered trademark of Reckitt Benckiser LLC.

Pregnancy/breastfeeding (PREGNANCY/BREASTFEEDING)

ask a health professional before use.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Stop Use and Ask Doctor If (STOP USE AND 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)

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)

Advanced Ingredient Data

[{"name": "CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)", "unii": "Z135WT9208", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE 2910 (5 MPA.S)", "unii": "R75537T0T4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A", "unii": "H8AV0SQX4D", "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": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "1200", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)", "unii": "Z135WT9208", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE 2910 (5 MPA.S)", "unii": "R75537T0T4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A", "unii": "H8AV0SQX4D", "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": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "600", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

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", "WARNINGS": "Do not use for children under 12 years of age", "DIRECTIONS": "do not crush, chew, or break 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 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours(For 600mg) adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.(For 1200mg) 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 20-25°C (68-77°F)", "ACTIVE INGREDIENT(S)": "Guaifenesin 600 mg (for 600mg) Guaifenesin 1200 mg (for 1200 mg)", "INACTIVE INGREDIENTS": "carbomer homopolymer type B; hypromellos, magnesium stearate, microcrystalline cellulose, sodium starch glycolate", "QUESTIONS OR COMMENTS": "Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST. All trademarks are property of their respective owners.MUCINEX is the registered trademark of Reckitt Benckiser LLC.", "PREGNANCY/BREASTFEEDING": "ask a health professional before use.", "STOP USE AND 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)", "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)"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:00:30.864269 · Updated: 2026-03-14T23:13:05.198485