LORATADINE tablet, chewable

LORATADINE by

Drug Labeling and Warnings

LORATADINE by is a Otc medication manufactured, distributed, or labeled by Rite Aid, Ohm Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• 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, D&C red No. 27 aluminum lake, FD&C blue No. 2 aluminum lake, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

Questions?

call 1-800-406-7984

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton

RITE
AID®
PHARMACY

*Compare to the active ingredient
in Children's Claritin® Chewables

children's

allergy relief

loratadine chewable tablets USP, 5 mg

INDOOR &
OUTDOOR ALLERGIES
antihistamine

NON-DROWSY†

24 hour relief of:

sneezing
runny nose
itchy, watery eyes
itchy throat or nose

ages 2 years
& older

†WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.

grape flavored

ACTUAL
SIZE

30
CHEWABLE
TABLETS

The chewable tablets are to be chewed before swallowing.

INGREDIENTS AND APPEARANCE

LORATADINE 
loratadine tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-7240
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)
D&C RED NO. 27 (UNII: 2LRS185U6K)
ALUMINUM OXIDE (UNII: LMI26O6933)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
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	PURPLE (light to medium purple with a slightly speckled appearance)	Score	no score
Shape	ROUND (Flat face, beveled edge)	Size	10mm
Flavor	GRAPE	Imprint Code	753
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-7240-0	1 in 1 CARTON	04/01/2018
1		30 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	04/01/2018

Labeler - Rite Aid (014578892)

Registrant - Ohm Laboratories (184769029)

Establishment
Name	Address	ID/FEI	Business Operations
Ohm Laboratories		184769029	MANUFACTURE(11822-7240)