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
•: sneezing
•: itchy, watery eyes
•: 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.

Keep the carton. It contains important information. See end panel for expiration date.

DISTRIBUTED BY:
RITE AID
30 HUNTER LANE,
CAMP HILL, PA 17011

PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Carton

DYE-FREE CHILDRENS LORATADINE
loratadine tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11822-9999
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)
sodium starch glycolate type a potato (UNII: 5856J3G2A2)
stearic acid (UNII: 4ELV7Z65AP)

Product Characteristics
Color	WHITE (white to off-white)	Score	no score
Shape	ROUND (beveled edge)	Size	10mm
Flavor	BUBBLE GUM	Imprint Code	112
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11822-9999-3	3 in 1 CARTON	04/01/2022
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	04/01/2022

Labeler - RITE AID (014578892)

Name	Address	ID/FEI	Business Operations
Establishment
Ohm Laboratories		184769029	MANUFACTURE(11822-9999)

Dye-Free Children's Allergy Relief