CHILDRENS LORATADINE- loratadine tablet, chewable 
SAFEWAY

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CHILDREN'S LORATADINE

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:

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 overchew 2 tablets daily; not more than 2 tablets in 24 hours
children 2 to under 6 years of agechew 1 tablet daily; not more than 1 tablet in 24 hours
children under 2 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other information

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.

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

*When taken as directed. See Drug Facts Panel.

The chewable tablets are to be chewed before swallowing.

20 CHEWABLE
TABLETS

Principal Display Panel - 5 mg Tablet Blister Pack Carton
CHILDRENS LORATADINE 
loratadine tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-999
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorPURPLE (light purple to dark purple) Scoreno score
ShapeROUNDSize10mm
FlavorGRAPEImprint Code 753
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-999-202 in 1 CARTON07/01/2019
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21008807/01/2019
Labeler - SAFEWAY (009137209)
Registrant - OHM LABORATORIES INC. (184769029)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories184769029MANUFACTURE(21130-999)

Revised: 8/2019
Document Id: ba7cb110-d9f2-45f3-a21e-729345e8dd21
Set id: dad93ac1-ae0b-4918-8c62-92107e79a4b2
Version: 2
Effective Time: 20190807
 
SAFEWAY