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NDC 00363-0725-15 Loratadine and Pseudoephedrine 10; 240 mg/1; mg/1 Details

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

Loratadine and Pseudoephedrine is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreen Company. 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: 00363-0725-15
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: 00363-0725-15
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pseudoephedrine

Product Information

NDC	00363-0725
Product ID	0363-0725_0c2d87ca-fff0-46d5-9800-756693969a77
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
Proprietary Name Suffix	n/a
Non-Proprietary Name	Loratadine and Pseudoephedrine
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	Walgreen Company
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 00363-0725-15 (00363072515)

Pricing Information	N/A
NDC Package Code	0363-0725-15
Billing NDC	00363072515
Package	1 BLISTER PACK in 1 CARTON (0363-0725-15) / 15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date	2013-11-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ab7e4406-997a-43be-af99-a07a2da870da Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients (in each tablet)	Purpose
Loratadine, USP 10 mg	Antihistamine
Pseudoephedrine sulfate, USP 240 mg	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.
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

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

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

ORIGINAL PRESCRIPTION STRENGTH

NDC 0363-0725-15

Walgreens

Compare to the active ingredients in

Claritin-D ® 24 Hour††

•WALGREENS•

PHARMACIST RECOMMENDED†

NON-DROWSY*

Allergy Relief D

Nasal Decongestant

LORATADINE, USP 10 mg / ANTIHISTAMINE

PSEUDOEPHEDRINE SULFATE, USP 240 mg / NASAL DECONGESTANT

24 Hour

Indoor & Outdoor Allergies

Relief of nasal & sinus congestion due to colds or allergies
Relief of sneezing, runny nose, itchy, watery eyes & itchy throat or nose due to allegies

15

EXTENDED-RELEASE

TABLETS

*WHEN TAKEN AS DIRECTED.

SEE DRUG FACTS PANEL.

ACTUAL SIZE

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

INGREDIENTS AND APPEARANCE

LORATADINE AND PSEUDOEPHEDRINE

loratadine and pseudoephedrine tablet, film coated, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0725
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:0363-0725-56	1 in 1 CARTON	11/07/2013
1		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:0363-0725-69	1 in 1 CARTON	11/07/2013
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:0363-0725-15	1 in 1 CARTON	11/07/2013
3		15 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	ANDA076557	11/07/2013

Labeler - Walgreen Company (008965063)

Name	Address	ID/FEI	Business Operations
Establishment
Ohm Laboratories Inc.		051565745	manufacture(0363-0725)

Revised: 8/2021

Document Id: 0c2d87ca-fff0-46d5-9800-756693969a77

Set id: ab7e4406-997a-43be-af99-a07a2da870da

Version: 3

Effective Time: 20210825

Search by Drug Name or NDC

NDC 00363-0725-15 Loratadine and Pseudoephedrine 10; 240 mg/1; mg/1 Details

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

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 00363-0725-15 (00363072515)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL ab7e4406-997a-43be-af99-a07a2da870da Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

Warnings

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

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