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Loratadine by American Health Packaging

Medically reviewed on April 26, 2018

Dosage form: tablet
Ingredients: LORATADINE 10mg
Labeler: American Health Packaging
NDC Code: 68084-248

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:

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

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
  • store between 20° to 25°C (68° to 77°F)
  • protect from excessive moisture
  • FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Inactive Ingredients

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Questions?

for Ohm Laboratories call 1-800-406-7984

The drug product contained in this package is from NDC # 51660-526, Ohm Laboratories Inc.

Packaged and Distributed by:
American Health Packaging, Columbus, Ohio 43217

Principal Display Panel – Carton – 10 mg

NDC 68084-248-01

NON-DROWSY* 24 Hour Allergy Relief
Loratadine
Tablets, USP

10 mg

Antihistamine
Indoor & Outdoor Allergies

100 Tablets (10 x 10)

* When taken as directed. See Drug Facts Panel.

     

The drug product contained in this package is from
NDC # 51660-526, Ohm Laboratories Inc.

Packaged and Distributed by:
American Health Packaging, Columbus, Ohio 43217

801697
0224801/0418

Principal Display Panel – Blister – 10 mg

Allergy Relief
Loratadine
Tablet, USP           10 mg

LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68084-248(NDC:51660-526)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (LORATADINE) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
Product Characteristics
Colorwhite (White to Off White) Scoreno score
ShapeROUNDSize6mm
FlavorImprint CodeRX526
Contains    
Packaging
#Item CodePackage Description
1NDC:68084-248-01100 BLISTER PACK in 1 BOX, UNIT-DOSE
1NDC:68084-248-111 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07613411/09/2007
Labeler - American Health Packaging (929561009)
Establishment
NameAddressID/FEIOperations
American Health Packaging929561009repack(68084-248)

 
American Health Packaging

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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