LEADER ALLERGY RELIEF D-24- loratadine and pseudoephedrine sulfate tablet, film coated, extended release 
Cardinal Health

----------

Drug Facts

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

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

 
■ 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.

spl-10's-carton-label

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.

spl-15's-carton-label
LEADER ALLERGY RELIEF D-24 
loratadine and pseudoephedrine sulfate tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0162
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
PSEUDOEPHEDRINE SULFATE (UNII: Y9DL7QPE6B) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE SULFATE240 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScoreno score
ShapeCAPSULESize17mm
FlavorImprint Code RX724
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0162-110 in 1 BLISTER PACK; Type 0: Not a Combination Product01/15/2020
2NDC:70000-0162-215 in 1 BLISTER PACK; Type 0: Not a Combination Product01/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07655702/15/2017
Labeler - Cardinal Health (063997360)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.051565745MANUFACTURE(70000-0162)

Revised: 3/2022
Document Id: 2aa29226-da73-4113-9dbd-ed13b345464d
Set id: f1bcd2aa-e8cd-4364-87b4-c544537cdb50
Version: 4
Effective Time: 20220322
 
Cardinal Health