Active Ingredient (In Each Extended-Release Tablet)
Guaifenesin 600 mg
Mucus Relief Extended Release Tablet
FDA Label NDC 41520-731
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Care One (american Sales Company) for the product Mucus Relief Extended Release (NDC 41520-731). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each extended-release tablet), purpose, uses, do not use, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Expectorant
Uses
Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes 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 accopanied 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.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
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).
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 tablet 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° to 25°C (68° to 77°F)
Inactive Ingredients
carbomer, colloidal silicon dioxide, FD&C blue #1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, talc
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to the active ingredient in Mucinex®*
MUCUS RELIEF
Guaifenesin 600 mg
Expectorant
12 HOUR
RELIEVES CHEST CONGESTION
THINS AND LOOSEN MUCUS
EXTENDED-RELEASE TABLETS
*This product is not manufactured or distributed by Reckitt Benckiser LLC, distributor of Mucinex®.
TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY: FOODHOLD U.S.A., LLC
LANDOVER, MD 20785
Package Label
CAREONE Mucus Relief
* Please review the disclaimer below.
