CHILDRENS LORATADINE- loratadine tablet, chewable

CHILDRENS LORATADINE by

Drug Labeling and Warnings

CHILDRENS LORATADINE by is a Otc medication manufactured, distributed, or labeled by SAFEWAY, OHM LABORATORIES INC., 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

• 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, 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 toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984.

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY
BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA
94566-0009

PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton

Signature
care™
Quality
Guaranteed

Compare to
Children's Claritin® Chewables
active ingredient†

NDC: 21130-999-20

24 Hour | Non-Drowsy*

Children's Allergy Relief

AGES 2 YEARS & OLDER

LORATADINE CHEWABLE TABLETS USP, 5 mg Antihistamine

GRAPE FLAVOR

Actual Size

• Indoor & outdoor allergies
• Relief of: Sneezing; runny nose; itchy, watery eyes; itchy throat or nose

*When taken as directed. See Drug Facts Panel.

The chewable tablets are to be chewed before swallowing.

20 CHEWABLE
TABLETS

INGREDIENTS AND APPEARANCE

CHILDRENS LORATADINE 
loratadine tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-999
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)
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	753
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21130-999-20	2 in 1 CARTON	07/01/2019
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	07/01/2019

Labeler - SAFEWAY (009137209)

Registrant - OHM LABORATORIES INC. (184769029)

Establishment
Name	Address	ID/FEI	Business Operations
Ohm Laboratories		184769029	MANUFACTURE(21130-999)