Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (600 mg)

Inactive Ingredients

Silicon Dioxide Hypromellose 2208 (15000 Mpa.s) Hypromellose 2910 (10000 Mpa.s) Magnesium Stearate Microcrystalline Cellulose 101 Microcrystalline Cellulose 102 Povidone K90 Povidone K25 Starch, Corn

Identifiers & Packaging

Pill Appearance

Imprint: L;68 Shape: oval Color: white Size: 16 mm Score: 1

Marketing Status

ANDA Active Since 2026-01-23

Medication Information

Purpose

Expectorant

Description

(in each extended-release tablet) Guaifenesin USP 600 mg

Uses

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 extended-release 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 extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours
children under 12 years of age: do not use

Questions?

1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)

DISTRIBUTED BY:

WHOLE FOODS MARKET

550 BOWIE STREET, AUSTIN, TX 78703

©2025 WHOLE FOODS MARKET IP, INC.

www.wholefoodsmarket.com

PRODUCT OF INDIA

Active Ingredient

(in each extended-release tablet)

Guaifenesin USP 600 mg

Other Information

store between 20° to 25°C (68° to 77°F)

Inactive Ingredients

colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinised starch (maize)

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 600 Mg (20 Tablets Container Label)

365

WHOLE FOODS

MARKET

NDC 42681-0057-1

Expectorant

Mucus Relief

Guaifenesin

Extended-Release Tablets 600mg

Guaifenesin 600mg- Expectorant

Relieves Chest Congestion

Thins & Loosens Mucus

12 20

Hour Extended-Release

TABLETS

Package Label Principal Display Panel 600 Mg (20 Tablets Container Carton)

365

WHOLE FOODS

MARKET

NDC 42681-0057-1

Expectorant

Mucus Relief

Guaifenesin

Extended-Release Tablets 600mg

Guaifenesin 600mg - Expectorant

Compare to the Active Ingredient in Mucinex^®**

Relieves Chest Congestion

Thins & Loosens Mucus

12 Hour

for Day or Night

ACTUAL SIZE 20

Extended-Release

TABLETS

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

Warnings

Do not use

for children under 12 years of age

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 the timing of meals
adults and children 12 years of age and over: 1 or 2 extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours
children under 12 years of age: do not use

Questions?

1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)

DISTRIBUTED BY:

WHOLE FOODS MARKET

550 BOWIE STREET, AUSTIN, TX 78703

©2025 WHOLE FOODS MARKET IP, INC.

www.wholefoodsmarket.com

PRODUCT OF INDIA

Active Ingredient (Active ingredient)

(in each extended-release tablet)

Guaifenesin USP 600 mg

Other Information (Other information)

store between 20° to 25°C (68° to 77°F)

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinised starch (maize)

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 600 Mg (20 Tablets Container Label) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg (20 Tablets Container Label))

365

WHOLE FOODS

MARKET

NDC 42681-0057-1

Expectorant

Mucus Relief

Guaifenesin

Extended-Release Tablets 600mg

Guaifenesin 600mg- Expectorant

Relieves Chest Congestion

Thins & Loosens Mucus

12 20

Hour Extended-Release

TABLETS

Package Label Principal Display Panel 600 Mg (20 Tablets Container Carton) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg (20 Tablets Container Carton))

365

WHOLE FOODS

MARKET

NDC 42681-0057-1

Expectorant

Mucus Relief

Guaifenesin

Extended-Release Tablets 600mg

Guaifenesin 600mg - Expectorant

Compare to the Active Ingredient in Mucinex^®**

Relieves Chest Congestion

Thins & Loosens Mucus

12 Hour

for Day or Night

ACTUAL SIZE 20

Extended-Release

TABLETS

Advanced Ingredient Data

[{"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "600", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE 2208 (15000 MPA.S)", "unii": "Z78RG6M2N2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE 2910 (10000 MPA.S)", "unii": "0HO1H52958", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE 101", "unii": "7T9FYH5QMK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE 102", "unii": "PNR0YF693Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE K90", "unii": "RDH86HJV5Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE K25", "unii": "K0KQV10C35", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "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", "Warnings": "Do not use for children under 12 years of age", "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 the timing of meals adults and children 12 years of age and over: 1 or 2 extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours children under 12 years of age: do not use", "Questions?": "1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) DISTRIBUTED BY: WHOLE FOODS MARKET 550 BOWIE STREET, AUSTIN, TX 78703 ©2025 WHOLE FOODS MARKET IP, INC. www.wholefoodsmarket.com PRODUCT OF INDIA", "Active ingredient": "(in each extended-release tablet) Guaifenesin USP 600 mg", "Other information": "store between 20° to 25°C (68° to 77°F)", "Inactive ingredients": "colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinised starch (maize)", "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 - 600 mg (20 Tablets Container Label)": "365 WHOLE FOODS MARKET NDC 42681-0057-1 Expectorant Mucus Relief Guaifenesin Extended-Release Tablets 600mg Guaifenesin 600mg- Expectorant Relieves Chest Congestion Thins & Loosens Mucus 12 20 Hour Extended-Release TABLETS", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg (20 Tablets Container Carton)": "365 WHOLE FOODS MARKET NDC 42681-0057-1 Expectorant Mucus Relief Guaifenesin Extended-Release Tablets 600mg Guaifenesin 600mg - Expectorant Compare to the Active Ingredient in Mucinex ®** Relieves Chest Congestion Thins & Loosens Mucus 12 Hour for Day or Night ACTUAL SIZE 20 Extended-Release TABLETS"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information