DailyMed - LORATADINE tablet, chewable

NDC Code(s): 0363-9985-30, 0363-9985-60
Packager: WALGREENS CO.

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 19, 2024

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SPL UNCLASSIFIED SECTION
Drug Facts

Drug Facts
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Active ingredient (in each chewable tablet)
Loratadine USP, 5 mg

Loratadine USP, 5 mg
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Purpose
Antihistamine

Antihistamine
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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
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
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Warnings
Do not useif you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine ...

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

Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine if you need a different dose.

When using this productdo not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask a doctor ifan 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).

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Directions

chew or crush tablets completely before swallowing. adults and children 6 years and overchew 2 tablets daily; not more than 2 chewable tablets in 24 hours - children 2 to under 6 years of ...

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 ...
- 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).
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Inactive ingredients
aspartame, citric acid anhydrous, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

aspartame, citric acid anhydrous, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid
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Questions?
call toll-free Monday to Friday 8:30 am to 5:00 pm EST at - 1-800-406-7984.

call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984.
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SPL UNCLASSIFIED SECTION
DISTRIBUTED BY: WALGREEN CO. 200 WILMOT RD., DEERFIELD, IL 60015

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
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PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton-30 count
NDC 0363-9985-30 - Walgreens - Compare to the active ingredient - in Children's Claritin - ®Chewables - †† • WALGREENS • PHARMACIST RECOMMENDED - † Children's - Allergy Relief ...
NDC 0363-9985-30

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

30 CHEWABLE TABLETS
Chewable tablets are to be chewed before swallowing.

ACTUAL SIZE

Grape
flavor

*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.

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PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton-60 count
NDC 0363-9985-60 - Walgreens - Compare to the active ingredient - in Children's Claritin ®Chewables †† • WALGREENS • PHARMACIST RECOMMENDED † Children's - Allergy Relief - LORATADINE ...

NDC 0363-9985-60

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

60 CHEWABLE TABLETS
Chewable tablets are to be chewed before swallowing.

ACTUAL SIZE

Grape
flavor

*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.

Close

INGREDIENTS AND APPEARANCE

Product Information

Establishment
Name	Address	ID/FEI	Business Operations
Ohm Laboratories Inc.		184769029	manufacture(0363-9985)

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	RxCUI	RxNorm NAME	RxTTY
1	665078	loratadine 5 MG 24HR Chewable Tablet	PSN
2	665078	loratadine 5 MG Chewable Tablet	SCD

Label: LORATADINE tablet, chewable

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

	NDC
1	0363-9985-30
2	0363-9985-60

Label: LORATADINE tablet, chewable

View Package Photos

Drug Label Info

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Drug Label Information

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Safety

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LORATADINE tablet, chewable

Number of versions: 1

LORATADINE tablet, chewable

LORATADINE tablet, chewable

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LORATADINE tablet, chewable

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.