FDA Label for Leader Allergy Relief D-24

View Indications, Usage & Precautions

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:

  •  ■ sneezing ■ itchy, watery eyes ■ runny nose ■ itching of the nose or throat
  • ■ 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



  •  ■ 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



  •  ■ sodium: contains 10 mg/tablet ■ calcium: contains 25 mg/tablet
  • 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.