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NDC 70000-0504-03 Leader Allergy Relief D12 5; 120 mg/1; mg/1 Details

Leader Allergy Relief D12 5; 120 mg/1; mg/1

Leader Allergy Relief D12 is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health 110, LLC. dba Leader. The primary component is LORATADINE; PSEUDOEPHEDRINE SULFATE.

MedlinePlus Drug Summary

Loratadine is used to temporarily relieve the symptoms of hay fever (allergy to pollen, dust, or other substances in the air) and other allergies. These symptoms include sneezing, runny nose, and itchy eyes, nose, or throat. Loratadine is also used to treat itching and redness caused by hives. However, loratadine does not prevent hives or other allergic skin reactions. Loratadine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. Loratadine is also available in combination with pseudoephedrine (Sudafed, others). This monograph only includes information about the use of loratadine alone. If you are taking the loratadine and pseudoephedrine combination product, read the information on the package label or ask your doctor or pharmacist for more information.

Related Packages: 70000-0504-03
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Loratadine

Pseudoephedrine is used to relieve nasal congestion caused by colds, allergies, and hay fever. It is also used to temporarily relieve sinus congestion and pressure. Pseudoephedrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Pseudoephedrine is in a class of medications called nasal decongestants. It works by causing narrowing of the blood vessels in the nasal passages.

Related Packages: 70000-0504-03
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Pseudoephedrine

Product Information

NDC	70000-0504
Product ID	70000-0504_ae900734-0351-4a74-98a0-4af543e1882d
Associated GPIs	43993002597430
GCN Sequence Number	017181
GCN Sequence Number Description	loratadine/pseudoephedrine TAB ER 12H 5 MG-120MG ORAL
HIC3	Z2O
HIC3 Description	2ND GEN ANTIHISTAMINE AND DECONGESTANT COMBINATION
GCN	63570
HICL Sequence Number	006605
HICL Sequence Number Description	LORATADINE/PSEUDOEPHEDRINE SULFATE
Brand/Generic	Generic
Proprietary Name	Leader Allergy Relief D12
Proprietary Name Suffix	n/a
Non-Proprietary Name	loratadine, Pseudoephedrine sulfate
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED, EXTENDED RELEASE
Route	ORAL
Active Ingredient Strength	5; 120
Active Ingredient Units	mg/1; mg/1
Substance Name	LORATADINE; PSEUDOEPHEDRINE SULFATE
Labeler Name	Cardinal Health 110, LLC. dba Leader
Pharmaceutical Class	Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA076050
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70000-0504-03 (70000050403)

Pricing Information
NDC Package Code	70000-0504-3
Billing NDC	70000050403
Package	30 BLISTER PACK in 1 CARTON (70000-0504-3) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date	2020-01-09
NDC Exclude Flag	N
Price Per Unit	0.84267
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	ALLERGY RELIEF D-12 TABLET
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 98bd6186-2bd2-4f46-99df-f509bb00e03a Details

Active ingredients (in each tablet)

Loratadine 5 mg

Pseudoephedrine sulfate 120 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
•: temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
•: reduces swelling of nasal passages
•: temporarily relieves sinus congestion and pressure
•: 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 every 12 hours; not more than 2 tablets in 24 hours
children under 12 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other information

•: each tablet contains: calcium 25 mg
•: do not use if blister unit is broken or torn
•: store between 20° to 25°C (68° to 77°F)
•: keep in a dry place

Inactive ingredients

croscarmellose sodium, dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium stearate, pharmaceutical ink, povidone, titanium dioxide

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Non-Drowsy* | 12 Hour

Allergy Relief D-12

Pseudoephedrine Sulfate, 120 mg | Loratadine, 5 mg

Extended-Release Tablets

Nasal Decongestant | Antihistamine

Allergy and Congestion

Indoor and Outdoor Allergies

Relief of: - Nasal and Sinus Congestion Due to Colds or Allergies

Sneezing – Runny Nose – Itchy, Watery Eyes

Itchy Throat or Nose Due to Allergies

COMPARE TO CLARITIN-D® 12 HOUR EXTENDED RELEASE TABLETS active ingredients

*When Taken as Directed. See Drug Facts Panel.

10 EXTENDED RELEASE TABLETS

Actual Size

100% Money Back Guarantee

INGREDIENTS AND APPEARANCE

LEADER ALLERGY RELIEF D12

loratadine, pseudoephedrine sulfate tablet, film coated, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0504
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	5 mg
PSEUDOEPHEDRINE SULFATE (UNII: Y9DL7QPE6B) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE SULFATE	120 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (to off-white)	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	7U0
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70000-0504-3	30 in 1 CARTON	01/09/2020
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:70000-0504-2	20 in 1 CARTON	01/09/2020
2		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:70000-0504-1	10 in 1 CARTON	01/09/2020
3		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076050	01/09/2020

Labeler - Cardinal Health 110, LLC. dba Leader (063997360)

Revised: 6/2021

Document Id: ae900734-0351-4a74-98a0-4af543e1882d

Set id: 98bd6186-2bd2-4f46-99df-f509bb00e03a

Version: 3

Effective Time: 20210617