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allergy by Major Pharmaceuticals

Dosage form: tablet
Ingredients: LORATADINE 10mg
Labeler: Major Pharmaceuticals
NDC Code: 0904-5728

Major Pharmaceuticals Allergy 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 blister unit is broken or torn {Blister Only}
do not use if printed foil under cap is broken or missing {Bottle Only}
store between 20° to 25°C (68° to 77°F)
protect from excessive moisture {Blister Only}

Inactive ingredients

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

Questions or comments?

1-800-719-9260

Principal Display Panel

COMPARE TO the active ingredient of CLARITIN®

Original Prescription Strength

Non-Drowsy*

Allergy

Loratadine Tablets, 10 mg/Antihistamine

Indoor & Outdoor Allergies

Actual Size

24 HOUR

24 Hour Relief of

Sneezing; Runny Nose; Itchy, Watery Eyes; Itchy Throat or Nose

*When taken as directed. See Drug Facts Panel.

30 Tablets

ALLERGY 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5728
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (LORATADINE) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
POVIDONES 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize8mm
FlavorImprint CodeL612
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-5728-891 BOTTLE in 1 CARTON
190 TABLET in 1 BOTTLE
2NDC:0904-5728-8730 BLISTER PACK in 1 CARTON
21 TABLET in 1 BLISTER PACK
3NDC:0904-5728-1510 BLISTER PACK in 1 CARTON
31 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07630102/21/2005
Labeler - Major Pharmaceuticals (191427277)

Revised: 01/2015
 
Major Pharmaceuticals

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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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