LORATADINE tablet, chewable

Loratadine by

Drug Labeling and Warnings

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

Drug Details [pdf]

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 doctorbefore 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.

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° and 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

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

Distributed by:

Ohm Laboratories Inc.

New Brunswick, NJ 08901

0418

Principal Display Panel – 30 Chewable Tablet Blister Pack Carton

NDC: 30142-996-30

†Compare to the active ingredient of Children’s Claritin® Chewables

ages 2 years and older

Non-Drowsy

Children’s Allergy Relief

Loratadine Chewable Tablets USP, 5 mg

Antihistamine

Indoor & Outdoor Allergies

30 CHEWABLE TABLETS

The chewable tablets are to be chewed before swallowing.

Grape Flavored

24 Hour Relief Of:

• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Nose or Throat

*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: 30142-996
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)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
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	PURPLE (light purple to dark purple)	Score	no score
Shape	ROUND	Size	10mm
Flavor	GRAPE	Imprint Code	753
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30142-996-30	3 in 1 CARTON	05/22/2019
1		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	05/22/2019

Labeler - KROGER COMPANY (006999528)

Establishment
Name	Address	ID/FEI	Business Operations
Ohm Laboratories Inc.		184769029	MANUFACTURE(30142-996)