FDA Label for Mucinex
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH EXTENDED-RELEASE BI-LAYER TABLET)
- PURPOSE
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL
Mucinex Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health 107, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
* The name MUCINEX® and associated trademarked items are used with permission by Reckitt Benckiser
The drug product contained in this package is from NDC # 63824-008 Reckitt Benckiser.
Packaged and Distributed by American Health Packaging, 2550 John Glenn Avenue, Suite A, Columbus, OH 43217
Americanhealthpackaging.com
An AmerisourceBergen Company
Repackaged By:
Cardinal Health
Zanesville, OH 43701
057201
5500408/0915
L5315882-10617
Active Ingredient (In Each Extended-Release Bi-Layer Tablet)
Guaifenesin 600 mg
Purpose
Expectorant
12 Hour
Unique Bi-Layer Tablet
White Layer – Immediate Release Layer
Blue Layer – Extended-Release Layer
Uses
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Do Not Use
• for children under 12 years of age
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)
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - 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.
This Unit Dose package is not child resistant and is Intended for Institutional Use Only. KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.
If dispensed for outpatient use, a child-resistant container should be utilized.
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
• FOR YOUR PROTECTION: Do not use if blister is torn or broken.• 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
Questions?
1-866-MUCINEX (1-866-682-4639) for information about the drug product or to report side effects. For information about packaging, contact American Health Packaging at 1-800-707-4621.
Principal Display Panel
Mucinex 600 mg
Guaifenesin
EXPECTORANT
10 Extended-Release Bi-Layer Tablets
* Please review the disclaimer below.