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NDC 00904-5833-15 Loratadine and Pseudoephedrine Sulfate 10; 240 mg/1; mg/1 Details

Loratadine and Pseudoephedrine Sulfate 10; 240 mg/1; mg/1

Loratadine and Pseudoephedrine Sulfate is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Major Pharmaceuticals. 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: 00904-5833-15
Last Updated: 11/30/2022
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: 00904-5833-15
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pseudoephedrine

Product Information

NDC	00904-5833
Product ID	0904-5833_be7d6dd8-6b4c-47c2-9f23-da06169b1c3f
Associated GPIs	43993002597520
GCN Sequence Number	027622
GCN Sequence Number Description	loratadine/pseudoephedrine TAB ER 24H 10MG-240MG ORAL
HIC3	Z2O
HIC3 Description	2ND GEN ANTIHISTAMINE AND DECONGESTANT COMBINATION
GCN	63577
HICL Sequence Number	006605
HICL Sequence Number Description	LORATADINE/PSEUDOEPHEDRINE SULFATE
Brand/Generic	Generic
Proprietary Name	Loratadine and Pseudoephedrine Sulfate
Proprietary Name Suffix	n/a
Non-Proprietary Name	Loratadine and Pseudoephedrine Sulfate
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED, EXTENDED RELEASE
Route	ORAL
Active Ingredient Strength	10; 240
Active Ingredient Units	mg/1; mg/1
Substance Name	LORATADINE; PSEUDOEPHEDRINE SULFATE
Labeler Name	Major Pharmaceuticals
Pharmaceutical Class	Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA076557
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00904-5833-15 (00904583315)

Pricing Information
NDC Package Code	0904-5833-15
Billing NDC	00904583315
Package	10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0904-5833-15)
Marketing Start Date	2004-11-17
NDC Exclude Flag	N
Price Per Unit	0.57422
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	LORATADINE-D 24HR 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 2620a150-4a2c-4fa2-a0e4-6aafe9e496c3 Details

ACTIVE INGREDIENTS (IN EACH TABLET)

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 IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE. (for bottle cartons/labels only)
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

INACTIVE INGREDIENTS

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

Keep the carton. It contains important information.

See end panel for expiration date.

SPL UNCLASSIFIED SECTION

Distributed By

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

PRINCIPAL DISPLAY PANEL - 240 mg/10 mg Tablet Blister Pack Carton

MAJOR®

NDC 0904-5833-15

Compare to active ingredients of

Claritin-D® 24 Hour**

Original Prescription Strength

Non-Drowsy*

Loratadine•D

Extended-Release

Tablets

Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant

Loratadine, USP 10 mg/Antihistamine

Indoor & Outdoor Allergies

Allergy & Congestion

24

HOUR

Relief of:

Nasal and Sinus Congestion Due to Colds or Allergies

Sneezing; Runny Nose; Itchy, Watery Eyes;

Itchy Throat or Nose Due to Allergies

*When taken as directed. See Drug Facts Panel.

10

Extended-Release

Tablets

PRINCIPAL DISPLAY PANEL - 240 mg/10 mg Tablet Blister Pack Carton

INGREDIENTS AND APPEARANCE

LORATADINE AND PSEUDOEPHEDRINE SULFATE

loratadine and pseudoephedrine sulfate tablet, film coated, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-5833
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg
PSEUDOEPHEDRINE SULFATE (UNII: Y9DL7QPE6B) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE SULFATE	240 mg

Ingredient Name	Strength
Inactive Ingredients
CALCIUM CARBONATE (UNII: H0G9379FGK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SODIUM ALGINATE (UNII: C269C4G2ZQ)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white (white to off-white)	Score	no score
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code	RX724
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0904-5833-15	10 in 1 BLISTER PACK; Type 0: Not a Combination Product	11/17/2004
2	NDC:0904-5833-48	15 in 1 BLISTER PACK; Type 0: Not a Combination Product	11/17/2004

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076557	11/17/2004

Labeler - Major Pharmaceuticals (191427277)

Registrant - Sun Pharmaceutical Industries Inc. (146974886)

Name	Address	ID/FEI	Business Operations
Establishment
Ohm Laboratories Inc.		051565745	manufacture(0904-5833)

Revised: 12/2019

Document Id: be7d6dd8-6b4c-47c2-9f23-da06169b1c3f

Set id: 2620a150-4a2c-4fa2-a0e4-6aafe9e496c3

Version: 3

Effective Time: 20191226