FDA Label for Mucus Relief Maximum Strength
View Indications, Usage & Precautions
- 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.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
- PACKAGE LABEL
Mucus Relief Maximum Strength Product Label
The following document was submitted to the FDA by the labeler of this product Care One (american Sales Company). 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.
Active Ingredient (In Each Extended-Release Tablet)
Guaifenesin 1200 mg
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 tablet every 12 hours. Do not exceed 2 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 Maximum Strength Mucinex®*
MAXIMUM STRENGTH
MUCUS RELIEF
Guaifenesin 1200 mg
Expectorant
12 HOUR RELIEF
RELIEVES CHEST CONGESTION
THINS AND LOOSENS MUCUS
EXTENDED-RELEASE TABLETS
*This product is not manufactured or distributed by Reckitt Benckiser LLC, distributor of Maximum Strength 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
CARE ONE Mucus Relief
* Please review the disclaimer below.