Mucinex®

Mucinex®
SPL v1
SPL
SPL Set ID 1c84bf00-ebaa-4e69-a2c6-716631d209d9
Route
ORAL
Published
Effective Date 2008-08-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (600 mg)
Inactive Ingredients
Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked) Fd&c Blue No. 1 Aluminum Oxide Hypromelloses Magnesium Stearate Cellulose, Microcrystalline 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
  • 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; FD&C blue #1 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count 600 mg
60 67544-149-53
120 67544-149-70
180 67544-149-80

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:



Cookeville, TN 38506



20171218DKJ

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.
Principal Display Panel 600mg

NDC 67544-149 Guaifenesin (Mucinex) ER 600mg - Rx Only

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)
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)
  • 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; FD&C blue #1 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count 600 mg
60 67544-149-53
120 67544-149-70
180 67544-149-80

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:



Cookeville, TN 38506



20171218DKJ

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.
Principal Display Panel 600mg (PRINCIPAL DISPLAY PANEL - 600mg)

NDC 67544-149 Guaifenesin (Mucinex) ER 600mg - Rx Only

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)
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)