ALLERGY RELIEF- loratadine tablet, orally disintegrating 
Ohm Laboratories Inc.

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Drug Facts

ACTIVE INGREDIENT (IN EACH TABLET)

Loratadine, USP 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

  • place 1 tablet on tongue; tablet disintegrates, with or without water
  • 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

  • Phenylketonurics: Contains Phenylalanine 0.6 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). Protect from excessive moisture.
  • keep in a dry place.
  • use tablet immediately after opening individual blister.

INACTIVE INGREDIENTS

aspartame, croscarmellose sodium, fruit flavors, magnesium stearate, mannitol, sodium stearyl fumarate

QUESTIONS?

call 1-800-406-7984

KEEP THE CARTON. IT CONTAINS IMPORTANT INFORMATION. SEE END PANEL FOR EXPIRATION DATE.

Distributed by:

Ohm Laboratories Inc.

1385 Livingston Avenue

North Brunswick, NJ 08902

PRINCIPAL DISPLAY PANEL

Ohm®

NDC 51660-527-31

Original Prescription Strength

Non-Drowsy*

24 Hour

Allergy Relief

Loratadine Orally Disintegrating Tablets, 10 mg

Antihistamine

Indoor & Outdoor Allergies

No Water Needed

Melts in Your Mouth

For Adults and Children six years and older!

Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

30 Orally Disintegrating Tablets

*When taken as directed. See Drug Facts Panel.

This is the 30 count Ohm Loratadine orally disintegrating tablets, 10 mg.

ALLERGY RELIEF 
loratadine tablet, orally disintegrating
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:51660-527
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (LORATADINE) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
MANNITOL 
CROSCARMELLOSE SODIUM 
ASPARTAME 
SODIUM STEARYL FUMARATE 
MAGNESIUM STEARATE 
Product Characteristics
Colorwhite (white to off-white) Scoreno score
ShapeROUND (flat face beveled edged) Size10mm
FlavorSTRAWBERRY, TUTTI FRUTTI, MINTImprint Code RC17
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51660-527-313 in 1 CARTON
1NDC:51660-527-6910 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07715308/31/2007
Labeler - Ohm Laboratories Inc. (184769029)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.051565745manufacture

Revised: 6/2012
Document Id: 51144e84-67a5-4b12-baa3-4d167f67db6c
Set id: de3a7725-5d1b-4195-a9f8-43f92888997c
Version: 3
Effective Time: 20120625
 
Ohm Laboratories Inc.