FDA Label for Allergy Congestion Relief
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH TABLET)
- PURPOSE
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- WHEN USING THIS PRODUCT DO NOT TAKE MORE THAN DIRECTED.
- 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?
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Allergy Congestion Relief 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 Ingredients (In Each Tablet)
Loratadine 10 mg
Pseudoephedrine sulfate 240 mg
Purpose
Antihistamine
Nasal decongestant
Uses
• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:• sneezing• itchy, watery eyes• runny nose• itching of the nose or throat• temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies• reduces swelling of nasal passages• temporarily relieves sinus congestion and pressure• temporarily restores freer breathing through the nose
Do Not Use
• if you have ever had an allergic reaction to this product or any of its ingredients• 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• thyroid disease• high blood pressure• diabetes• trouble urinating due to an enlarged prostate gland• liver or kidney disease. Your doctor should determine if you need a different dose.
When Using This Product Do Not Take More Than Directed.
Taking more than directed may cause drowsiness.
Stop Use And Ask A Doctor If
• an allergic reaction to this product occurs. Seek medical help right away.• symptoms do not improve within 7 days or are accompanied by a fever• nervousness, dizziness or sleeplessness occurs
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 divide, crush, chew or dissolve the tablet
adults and children 12 years and over | 1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours |
children under 12 years of age | ask a doctor |
consumers with liver or kidney disease | ask a doctor |
Other Information
• do not use if printed blister unit is broken or torn• store between 20° to 25°C (68° to 77°F)• protect from light and store in a dry place
Inactive Ingredients
colloidal silicon dioxide, ferric oxide, hydrogenated vegetable oil, hypromellose, magnesium stearate, polyethylene glycol, polyethylene oxide, propylene glycol, titanium dioxide
Questions Or Comments?
1-800-632-6900
Package/Label Principal Display Panel
COMPARE TO the active ingredients of CLARITIN-D® 24 HOUR
See bottom panel
Kroger®
OUR PHARMACIST RECOMMENDED
Non-Drowsy*
Allergy & Congestion Relief
ACTUAL SIZE
RELIEF OF:
Nasal & Sinus
Congestion Due to Colds or Allergies;
Pseudoephedrine Sulfate 240 mg
Nasal Decongestant
Sneezing; Runny Nose; Itchy, Watery Eyes;
Itchy Throat or Nose Due to Allergies
Loratadine 10 mg
Antihistamine
Extended Release Tablets
INDOOR & OUTDOOR ALLERGIES
24 HOUR
15 EXTENDED-RELEASE TABLETS
*When taken as directed. See Drug Facts Panel.
* Please review the disclaimer below.