Active Ingredients
Loratadine, USP 10 mg
Pseudoephedrine Sulfate, USP 240 mg
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health for the product Leader Allergy Relief D-24 (NDC 70000-0162). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding 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,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Loratadine, USP 10 mg
Pseudoephedrine Sulfate, USP 240 mg
Antihistamine
Nasal Decongestant
■ 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
■ 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.
■ liver or kidney disease. Your doctor should determine if you need a different dose
Taking more than directed may cause drowsiness.
■ 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
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
■ 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 |
■ 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
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
call 1-800-406-7984
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.
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.