FDA Label for Sinus Decongestion
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- WHEN USING THIS PRODUCT
- 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
Sinus Decongestion Product Label
The following document was submitted to the FDA by the labeler of this product Kroger 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 Tablet)
Pseudoephedrine HCl 30 mg
Purpose
Nasal decongestant
Uses
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- temporarily relieves sinus congestion and pressure
Do Not Use
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask A Doctor Before Use If You Have
- heart disease
- diabetes
- thyroid disease
- high blood pressure
- difficulty in urination due to enlargement of the prostate gland
When Using This Product
do not exceed recommended dosage.
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occur
- symptoms do not improve within 7 days or occur with fever
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.
Directions
adults and children 12 years and over | take 2 tablets every 4 to 6 hours; do not take more than 8 tablets in 24 hours |
children ages 6 to 11 years | take 1 tablet every 4 to 6 hours; do not take more than 4 tablets in 24 hours |
children under 6 years | do not use |
Other Information
- each tablet contains: calcium 15 mg
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive Ingredients
croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silicon dioxide, titanium dioxide, triacetin
Questions Or Comments?
1-800-632-6900
Principal Display Panel
Kroger®
COMPARE TO the active ingredient of Sudafed® Sinus Congestion *see bottom panel
NDC 30142-641-22
Maximum Strength
Pseudoephedrine Hydrochloride tablets
Nasal Decongestant
NON-DROWSY
Relieves:
Nasal & Sinus congestion
Sinus Pressure
Actual Size
48 TABLETS
30 mg EACH
OUR PHARMACIST RECOMMENDED
DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202
FOR MORE PRODUCT INFORMATION,SCAN UPC
USING YOUR KROGER APP OR CALL 800-632-6900
*Sudafed is a registered trademark of
Johnson & Johnson Corporation, New Brunswick, NJ
08933. Johnson & Johnson Corporation is not affiliated
with The Kroger Co. or this product.
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TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
* Please review the disclaimer below.