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NDC 00363-9994-30 Loratadine 5 mg/1 Details

Loratadine 5 mg/1

Loratadine is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by WALGREENS CO.. The primary component is LORATADINE.

Product Information

NDC	00363-9994
Product ID	0363-9994_7aeb3f5b-33c7-4cf8-b6ab-5f3d211ea27c
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Loratadine
Proprietary Name Suffix	n/a
Non-Proprietary Name	Loratadine
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, CHEWABLE
Route	ORAL
Active Ingredient Strength	5
Active Ingredient Units	mg/1
Substance Name	LORATADINE
Labeler Name	WALGREENS CO.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA210088
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00363-9994-30 (00363999430)

Pricing Information	N/A
NDC Package Code	0363-9994-30
Billing NDC	00363999430
Package	3 BLISTER PACK in 1 CARTON (0363-9994-30) / 10 TABLET, CHEWABLE in 1 BLISTER PACK
Marketing Start Date	2020-08-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 71adc5b3-3a91-4a1f-acb3-78922a7d9d5a Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Loratadine USP, 5 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose
itchy, watery eyes
sneezing
itching of the nose or throat

Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have 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.

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

chew or crush tablets completely before swallowing.

adults and children 6 years and over	chew 2 tablets daily; not more than 2 tablets in 24 hours
children 2 to under 6 years of age	chew 1 tablet daily; not more than 1 tablet in 24 hours
children under 2 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other information

phenylketonurics: contains phenylalanine 1.25 mg per tablet.
TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
store between 20° to 25°C (68° to 77°F).

Inactive ingredients

aspartame, citric acid anhydrous, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

Questions?

call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984.

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton

NDC 0363-9994-30

Walgreens

Compare to the active ingredient

in Children's Claritin ®Chewables ††

• WALGREENS •

PHARMACIST RECOMMENDED†

Children's

Allergy Relief

LORATADINE CHEWABLE TABLETS USP, 5 mg / ANTIHISTAMINE

Dye Free

Non-Drowsy*

24-Hour Relief

24-hour relief of sneezing, runny nose, itchy throat or nose, & itchy, watery eyes
Indoor & outdoor allergies

AGES

2

YEARS &

OLDER

30 CHEWABLE TABLETS

Chewable tablets are to be chewed before swallowing.

ACTUAL SIZE

Grape

flavor

*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.

PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton

INGREDIENTS AND APPEARANCE

LORATADINE

loratadine tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-9994
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	5 mg

Ingredient Name	Strength
Inactive Ingredients
ASPARTAME (UNII: Z0H242BBR1)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	WHITE (white to off-white)	Score	no score
Shape	ROUND (beveled edge)	Size	10mm
Flavor	GRAPE	Imprint Code	106
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0363-9994-30	3 in 1 CARTON	08/01/2020
1		10 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	ANDA210088	08/01/2020

Labeler - WALGREENS CO. (008965063)

Name	Address	ID/FEI	Business Operations
Establishment
Ohm Laboratories Inc.		184769029	MANUFACTURE(0363-9994)

Revised: 8/2022

Document Id: 7aeb3f5b-33c7-4cf8-b6ab-5f3d211ea27c

Set id: 71adc5b3-3a91-4a1f-acb3-78922a7d9d5a

Version: 4

Effective Time: 20220809

Search by Drug Name or NDC

NDC 00363-9994-30 Loratadine 5 mg/1 Details

Loratadine 5 mg/1

Product Information

Package

Package Images

NDC 00363-9994-30 (00363999430)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 71adc5b3-3a91-4a1f-acb3-78922a7d9d5a Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each tablet)

Purpose

Uses

Warnings

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton

INGREDIENTS AND APPEARANCE

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