LORATADINE tablet, chewable

Loratadine by

Drug Labeling and Warnings

Loratadine by is a Otc medication manufactured, distributed, or labeled by WALGREENS CO., Ohm Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each chewable 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 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).

Directions

• chew or crush tablets completely before swallowing.

• 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

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-30 count

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.

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 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.

INGREDIENTS AND APPEARANCE

LORATADINE 
loratadine tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-9985
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
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	LC5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-9985-30	3 in 1 CARTON	03/15/2024
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 0363-9985-60	6 in 1 CARTON	03/15/2024
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA210088	08/01/2020

Labeler - WALGREENS CO. (008965063)

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