Leader allergy relief d-24 tablet, film coated, extended release

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:

  1. 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

Warnings

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

  1. 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

  1. 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

Ingredients and appearance - Product information

Leader allergy relief d-24 tablet, film coated, extended release- Loratadine and pseudoephedrine sulfate

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 70000-0162
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Loratadine ( UNII: 7AJO3BO7QN)( Loratadine - UNII: 7AJO3BO7QN ) 10 mgin 1
Pseudoephedrine sulfate ( UNII: Y9DL7QPE6B)( Pseudoephedrine - UNII: 7CUC9DDI9F ) 240 mgin 1

Inactive Ingredients

Ingredient Name Code
Calcium carbonate ( UNII: H0G9379FGK)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Starch, corn ( UNII: O8232NY3SJ)
Shellac ( UNII: 46N107B71O)
Sodium alginate ( UNII: C269C4G2ZQ)
Sodium citrate, unspecified form ( UNII: 1Q73Q2JULR)
Talc ( UNII: 7SEV7J4R1U)
Titanium dioxide ( UNII: 15FIX9V2JP)
Ferrosoferric oxide ( UNII: XM0M87F357)
Hydroxypropyl cellulose, unspecified ( UNII: 9XZ8H6N6OH)
Hypromellose, unspecified ( UNII: 3NXW29V3WO)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Povidone, unspecified ( UNII: FZ989GH94E)
Polyethylene glycol, unspecified ( UNII: 3WJQ0SDW1A)

Product Characteristics

Color white Size 17 mm
Shape CAPSULE Score 1
Imprint Code RX724

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA076557 USA

Labeler - Cardinal Health( 097537435)

Establishment

Name ID/FEI Business Operations
Cardinal Health 097537435 MANUFACTURE( 70000-0162)

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.