1203-qch-2024-0718

SPL v2

SPL

SPL Set ID b630357a-4166-4b30-8137-47ca3d579e79

Route

ORAL

Published

Effective Date 2024-07-18

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (600 mg)

Inactive Ingredients

Carbomer Homopolymer Type B (allyl Sucrose Crosslinked) Hypromellose 2910 (15 Mpa.s) Sodium Starch Glycolate Type A Magnesium Stearate Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance

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

Marketing Status

ANDA Active Since 2024-07-18

Description

Drug Facts

Purpose

Expectorant

Medication Information

Warnings and Precautions

Warnings

Purpose

Expectorant

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Section 50565-1

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).

Section 50566-9

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.

Section 50569-3

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)

Section 50570-1

Do not use

■ for children under 12 years of age

Section 53414-9

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

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

Other Information

■ store between 20-25ºC (68-77ºF)

■ retain carton for complete product information and warnings

Inactive Ingredients

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

Principal Display Panel

QUALITY CHOICE®

NDC 83324-097-20

†Compare to Active Ingredient in MUCINEX®

12 Hour

Mucus Relief

Guaifenesin Extended-Release Tablets, 600 mg

Expectorant

Relieves Chest Congestion

Thins & Loosens Mucus

Immediate and Extended Release

Actual Size

20 EXTENDED-RELEASE TABLETS

Active Ingredient (in Each Extended Release Tablet)

Guaifenesin 600 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

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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).

Section 50566-9 (50566-9)

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.

Section 50569-3 (50569-3)

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)

Section 50570-1 (50570-1)

Do not use

■ 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

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

Other Information (Other information)

■ store between 20-25ºC (68-77ºF)

■ retain carton for complete product information and warnings

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

QUALITY CHOICE®

NDC 83324-097-20

†Compare to Active Ingredient in MUCINEX®

12 Hour

Mucus Relief

Guaifenesin Extended-Release Tablets, 600 mg

Expectorant

Relieves Chest Congestion

Thins & Loosens Mucus

Immediate and Extended Release

Actual Size

20 EXTENDED-RELEASE TABLETS

Active Ingredient (in Each Extended Release Tablet) (Active ingredient (in each extended-release tablet))

Guaifenesin 600 mg

Advanced Ingredient Data

[{"name": "CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)", "unii": "Z135WT9208", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE 2910 (15 MPA.S)", "unii": "36SFW2JZ0W", "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)

{"Uses": "■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive", "34071-1": "Warnings", "42229-5": "Drug Facts", "50565-1": "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).", "50566-9": "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.", "50569-3": "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)", "50570-1": "Do not use ■ for children under 12 years of age", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Expectorant", "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", "Other information": "■ store between 20-25ºC (68-77ºF) ■ retain carton for complete product information and warnings", "Inactive ingredients": "carbomer homopolymer type B, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate", "PRINCIPAL DISPLAY PANEL": "QUALITY CHOICE® NDC 83324-097-20 †Compare to Active Ingredient in MUCINEX® 12 Hour Mucus Relief Guaifenesin Extended-Release Tablets, 600 mg Expectorant Relieves Chest Congestion Thins & Loosens Mucus Immediate and Extended Release Actual Size 20 EXTENDED-RELEASE TABLETS", "Active ingredient (in each extended-release tablet)": "Guaifenesin 600 mg"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:03:18.839848 · Updated: 2026-03-14T23:03:18.838207