Guaifenesin Extended-release Tablets, 600 Mg And 1200 Mg

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (600 mg)

Inactive Ingredients

Hypromellose 2910 (5 Mpa.s) Carbomer Homopolymer Type B (allyl Sucrose Crosslinked) Sodium Starch Glycolate Type A Potato Magnesium Stearate Microcrystalline Cellulose Hypromellose 2910 (10000 Mpa.s)

Identifiers & Packaging

Pill Appearance

Imprint: G;1200 Shape: oval Color: white Size: 16 mm Size: 22 mm Score: 1

Marketing Status

ANDA Active Since 2020-12-18

Medication Information

Purpose

Expectorant

Description

Guaifenesin 600 mg (for 600 mg) Guaifenesin 1200 mg (for 1200 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 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 (For 600 mg)
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. (For 1200 mg)
children under 12 years of age: do not use

Questions?

Contact 1-877-770-3183

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

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)

Inactive Ingredients

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

Principal Display Panel

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)

If Pregnant Or Breast Feeding,

ask a health professional before use.

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)

Principal Display Panel 600 Mg Blister Carton Label

NDC 62207- 839-72 Compare to the active ingredient

of Mucinex ^®

Guaifenesin

Extended-Release Tablets 600 mg

Guaifenesin 600 mg - Expectorant

RELIEVES CHEST CONGESTION

12HR FOR DAY • Relieves Chest Congestion

OR NIGHT • Thins and Loosens Mucus

• Immediate and Extended Release

90 (9 x 10) EXTENDED-RELEASE TABLETS

Principal Display Panel 1200 Mg Blister Carton Label

NDC 62207- 840-71 Compare to the active ingredient

of Mucinex ^®

Guaifenesin

Extended-Release Tablets 1200 mg

Maximum strength

Guaifenesin 1200 mg - Expectorant

RELIEVES CHEST CONGESTION

12HR FOR DAY • Relieves Chest Congestion

OR NIGHT • Thins and Loosens Mucus

• Immediate and Extended Release

70 (7 x 10) EXTENDED-RELEASE TABLETS

Active Ingredients (in Each Extended Release Tablet)

Guaifenesin 600 mg (for 600 mg)

Guaifenesin 1200 mg (for 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 (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 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 (For 600 mg)
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. (For 1200 mg)
children under 12 years of age: do not use

Questions?

Contact 1-877-770-3183

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

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)

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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)

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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)

Principal Display Panel 600 Mg Blister Carton Label (PRINCIPAL DISPLAY PANEL - 600 mg Blister Carton Label)

NDC 62207- 839-72 Compare to the active ingredient

of Mucinex ^®

Guaifenesin

Extended-Release Tablets 600 mg

Guaifenesin 600 mg - Expectorant

RELIEVES CHEST CONGESTION

12HR FOR DAY • Relieves Chest Congestion

OR NIGHT • Thins and Loosens Mucus

• Immediate and Extended Release

90 (9 x 10) EXTENDED-RELEASE TABLETS

Principal Display Panel 1200 Mg Blister Carton Label (PRINCIPAL DISPLAY PANEL - 1200 mg Blister Carton Label)

NDC 62207- 840-71 Compare to the active ingredient

of Mucinex ^®

Guaifenesin

Extended-Release Tablets 1200 mg

Maximum strength

Guaifenesin 1200 mg - Expectorant

RELIEVES CHEST CONGESTION

12HR FOR DAY • Relieves Chest Congestion

OR NIGHT • Thins and Loosens Mucus

• Immediate and Extended Release

70 (7 x 10) EXTENDED-RELEASE TABLETS

Active Ingredients (in Each Extended Release Tablet) (Active ingredients (in each extended-release tablet))

Guaifenesin 600 mg (for 600 mg)

Guaifenesin 1200 mg (for 1200 mg)

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", "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 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 (For 600 mg) 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. (For 1200 mg) children under 12 years of age: do not use", "Questions?": "Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.", "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)", "Inactive ingredients": "carbomer homopolymer type B; hypromellose; magnesium stearate; microcrystalline cellulose; sodium starch glycolate", "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)", "If pregnant or breast-feeding,": "ask a health professional before use.", "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)", "PRINCIPAL DISPLAY PANEL - 600 mg Blister Carton Label": "NDC 62207- 839 -72 Compare to the active ingredient of Mucinex ® Guaifenesin Extended-Release Tablets 600 mg Guaifenesin 600 mg - Expectorant RELIEVES CHEST CONGESTION 12HR FOR DAY • Relieves Chest Congestion OR NIGHT • Thins and Loosens Mucus • Immediate and Extended Release 90 (9 x 10) EXTENDED-RELEASE TABLETS", "PRINCIPAL DISPLAY PANEL - 1200 mg Blister Carton Label": "NDC 62207- 840 -71 Compare to the active ingre dient of Mucinex ® Guaifenesin Extended-Release Tablets 1200 mg Maximum strength Guaifenesin 12 00 mg - Expectorant RELIEVES CHEST CONGESTION 12HR FOR DAY • Relieves Chest Congestion OR NIGHT • Thins and Loosens Mucus • Immediate and Extended Release 70 (7 x 10) EXTENDED-RELEASE TABLETS", "Active ingredients (in each extended-release tablet)": "Guaifenesin 600 mg (for 600 mg) Guaifenesin 1200 mg (for 1200 mg)"}

Guaifenesin Extended-release Tablets, 600 Mg And 1200 Mg

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information