MEMBERS MARK LORATADINE- loratadine tablet 
Sam's West Inc

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Sam's West, Inc. Loratadine Tablets, 10 mg Drug Facts

Active ingredient (in each tablet)

Loratadine 10 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

1 tablet daily; not more than 1 tablet in 24 hours

children under 6 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

Other information

•
do not use if printed foil under cap is broken or missing
•
store between 20° to 25°C (68° to 77°F)

Inactive ingredients

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

Questions or comments?

1-800-809-0469

Principal Display Panel

Compare to Claritin® active ingredient

Original Prescription Strength

Loratadine Tablets 10 mg/Antihistamine

Indoor & Outdoor Allergies

24 hour relief of:

Sneezing

Runny nose

Itchy, watery eyes

Itchy throat or nose

Non-Drowsy*

*When taken as directed.

See drug facts panel.

actual size

400 Tablets

400 days of relief

Contains 2 bottles with 200 tablets each

loratidine image
MEMBERS MARK LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68196-612
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize8mm
FlavorImprint Code L612
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68196-612-152 in 1 CARTON05/21/200705/21/2007
1180 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:68196-612-872 in 1 CARTON05/26/201105/26/2011
2150 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:68196-612-792 in 1 PACKAGE02/28/201108/01/2021
3200 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07630105/21/200708/01/2021
Labeler - Sam's West Inc (051957769)

Revised: 10/2021
Document Id: 3ef02b34-695f-4bdb-a0a0-cb62877cb985
Set id: 915b4340-5441-49f3-8fd9-6f1cdbb4718d
Version: 6
Effective Time: 20211018
 
Sam's West Inc