FDA Label for Leader Allergy Relief D-24
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS
- 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
- INACTIVEINGREDIENTS
- QUESTIONS
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
Leader Allergy Relief D-24 Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health. 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
Loratadine, USP 10 mg
Pseudoephedrine Sulfate, USP 240 mg
Purpose
Antihistamine
Nasal Decongestant
Uses
■ temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
■ reduces swelling of nasal passages
■ temporarily relieves sinus congestion and pressure
■ temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
■ 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
■ 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
■ TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. (for blister cartons only)
■ store between 20° C to 25° C (68° F to 77° F).
■ protect from light and store in a dry place
Inactiveingredients
calcium carbonate, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, sodium alginate, sodium citrate, talc and titanium dioxide
Questions
call 1-800-406-7984
Package/Label Principal Display Panel
NDC 70000-0162-1
Original Prescription Strength
*Compare to the active ingredients of Claritin-D® 24 Hour
NON-DROWSY*
Allergy Relief D-24
Loratadine, USP 10 mg/Antihistamine
Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant
Indoor & Outdoor Allergies
Allergy & Congestion
Relief of:
Nasal & Sinus Congestion Due to Colds or Allergies
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose Due to Allergies
Allergy & Congestion
10 Extended-Release Tablets
*When taken as directed. See Drug Facts Panel.
Keep the carton. It contains important information.
see end panel for expiration date.
Principal Display Panel
NDC 70000-0162-2
Original Prescription Strength
*Compare to the active ingredients of Claritin-D® 24 Hour
NON-DROWSY**
Allergy Relief D-24
Loratadine, USP 10 mg/Antihistamine
Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant
Indoor & Outdoor Allergies
Allergy & Congestion
Relief of:
Nasal & Sinus Congestion Due to Colds or Allergies
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose Due to Allergies
Allergy & Congestion
15 Extended-Release Tablets
*When taken as directed. See Drug Facts Panel.
Keep the carton. It contains important information.
see end panel for expiration date.
* Please review the disclaimer below.