Your browser does not support JavaScript! LORATADINE TABLET [DIRECT RX]
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RxNorm Names

LORATADINE tablet
[DIRECT RX]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

USES

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nosesneezing
  • itchy, watery eyes
  • itching of the nose or throat

ACTIVE INGREDIENT IN EACH TABLET

Loratadine 10 mg

PURPOSE

Antihistamine

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.

Directions

image description

Other information

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

Questions or comments?

1-800-719-9260

INACTIVE INGREDIENTS

Inactive ingredients

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

KEEP OUT OF REACH OF CHILDREN

PRINCIPAL DISPLAY PANEL

Compare to Claritin® active ingredient

Loratadine Tablets, 10 mg

Antihistamine

24 Hour

Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

Indoor & Outdoor Allergies

Non-Drowsy*

*When taken as directed. See Drug Facts Panel.

10mg Label Image:

image description

LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:61919-142(NDC:45802-650)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (LORATADINE) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
POVIDONE 
STARCH, CORN 
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize8mm
FlavorImprint Code L612
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61919-142-1010 in 1 BOTTLE
1NDC:61919-142-3030 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07630101/01/2014
Labeler - DIRECT RX (079254320)
Establishment
NameAddressID/FEIBusiness Operations
DIRECT RX079254320repack(61919-142), relabel(61919-142)

Revised: 3/2014
 
DIRECT RX

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