Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (1200 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;69 Shape: oval Color: white Size: 21 mm Score: 1

Marketing Status

ANDA Active Since 2025-07-31

Medication Information

Purpose

Expectorant

Description

(in each extended-release tablet) Guaifenesin USP 1200 mg

Uses

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

Section 50570-1

for children under 12 years of age

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Warnings

Do not use

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

Active Ingredient

(in each extended-release tablet)

Guaifenesin USP 1200 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)

Questions?

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

DISTRIBUTED BY:

SAM'S WEST, INC.

BENTONVILLE AR 72716

Made in India

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).

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 1200 Mg Blister Carton (56 (4 X 14) Tablets)

Member's

Mark_™

COMPARE TO MAXIMUM STRENGTH

MUCINEX^®ACTIVE INGREDIENT*

NDC 68196-960-56

MAXIMUM STRENGTH

Mucus Relief

GUAIFENESIN EXTENDED-RELEASE TABLETS, 1200 mg

GUAIFENESIN 1200 mg-EXPECTORANT

Relieves chest congestion

Actual Size

56

Extended-Release

Tablets

Relieves chest congestion
Thins and loosens mucus

12

HR

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

Section 50570-1 (50570-1)

for children under 12 years of age

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Expectorant

Warnings

Do not use

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

Active Ingredient (Active ingredient)

(in each extended-release tablet)

Guaifenesin USP 1200 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)

Questions?

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

DISTRIBUTED BY:

SAM'S WEST, INC.

BENTONVILLE AR 72716

Made in India

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).

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 1200 Mg Blister Carton (56 (4 X 14) Tablets) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg Blister Carton (56 (4 x 14) Tablets))

Member's

Mark_™

COMPARE TO MAXIMUM STRENGTH

MUCINEX^®ACTIVE INGREDIENT*

NDC 68196-960-56

MAXIMUM STRENGTH

Mucus Relief

GUAIFENESIN EXTENDED-RELEASE TABLETS, 1200 mg

GUAIFENESIN 1200 mg-EXPECTORANT

Relieves chest congestion

Actual Size

56

Extended-Release

Tablets

Relieves chest congestion
Thins and loosens mucus

12

HR

Advanced Ingredient Data

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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", "50570-1": "for children under 12 years of age", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Expectorant", "Warnings": "Do not use", "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", "Active ingredient": "(in each extended-release tablet) Guaifenesin USP 1200 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) Questions? 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) DISTRIBUTED BY: SAM'S WEST, INC. BENTONVILLE AR 72716 Made in India", "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).", "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 - 1200 mg Blister Carton (56 (4 x 14) Tablets)": "Member's Mark ™ COMPARE TO MAXIMUM STRENGTH MUCINEX ® ACTIVE INGREDIENT* NDC 68196-960-56 MAXIMUM STRENGTH Mucus Relief GUAIFENESIN EXTENDED-RELEASE TABLETS, 1200 mg GUAIFENESIN 1200 mg-EXPECTORANT Relieves chest congestion Actual Size 56 Extended-Release Tablets Relieves chest congestion Thins and loosens mucus 12 HR "}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information