Mucinex 600mg Tablets

Mucinex 600mg Tablets
SPL v3
SPL
SPL Set ID bdae8726-ff98-4866-e053-2995a90ad67a
Route
ORAL
Published
Effective Date 2021-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (600 mg)
Inactive Ingredients
Fd&c Blue No. 1 Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked) Aluminum Oxide Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Sodium Starch Glycolate Type A Potato

Identifiers & Packaging

Pill Appearance
Imprint: Mucinex;600 Shape: oval Color: white Size: 16 mm Score: 1
Marketing Status
NDA Active Since 2012-07-03

Description

Drug Facts

Purpose

Expectorant


Medication Information

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.

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
Do Not Use
  • for children under 12 years of age
Questions?

1-866-MUCINEX (1-866-682-4639)

You may also report side effects to this phone number.

Other Information
  • store at 20-25°C (68-77°F)
Inactive Ingredients

carbomer homopolymer type B; FD&C blue #1 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

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.
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

Principal Display Panel 20 Tablet Blister Pack Carton

NDC 63824-008-32

Mucinex®

600 mg guaifenesin

extended-release bi-layer tablets

EXPECTORANT

12

HOUR ®

✓ Relieves Chest Congestion

✓ Thins and Loosens Mucus

✓ Immediate and Extended Release

20

EXTENDED-RELEASE

BI-LAYER TABLETS

Active Ingredient (in Each Extended Release Bi Layer 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
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.

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
Do Not Use (Do not use)
  • for children under 12 years of age
Questions?

1-866-MUCINEX (1-866-682-4639)

You may also report side effects to this phone number.

Other Information (Other information)
  • store at 20-25°C (68-77°F)
Inactive Ingredients (Inactive ingredients)

carbomer homopolymer type B; FD&C blue #1 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

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.
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 (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Principal Display Panel 20 Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 20 Tablet Blister Pack Carton)

NDC 63824-008-32

Mucinex®

600 mg guaifenesin

extended-release bi-layer tablets

EXPECTORANT

12

HOUR ®

✓ Relieves Chest Congestion

✓ Thins and Loosens Mucus

✓ Immediate and Extended Release

20

EXTENDED-RELEASE

BI-LAYER TABLETS

Active Ingredient (in Each Extended Release Bi Layer Tablet) (Active ingredient (in each extended-release bi-layer tablet))

Guaifenesin 600 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)