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
• ▪ 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 beast-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 (1800-222-1222).

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?

1800-632-6900

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

LORATADINE 
loratadine tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-984
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)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	PURPLE (light purple to dark purple)	Score	no score
Shape	ROUND	Size	10mm
Flavor	GRAPE	Imprint Code	106
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30142-984-30	3 in 1 CARTON	04/02/2021
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	04/02/2021

Labeler - KROGER COMPANY (006999528)

Establishment
Name	Address	ID/FEI	Business Operations
Ohm Laboratories Inc.		184769029	MANUFACTURE(30142-984)