LORATADINE by DirectRx

LORATADINE by

Drug Labeling and Warnings

LORATADINE by is a Otc medication manufactured, distributed, or labeled by DirectRx. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LORATADINE- loratadine tablet 
DirectRx

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Loratadine 10 mg

Antihistamine

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)


do not use if printed foil under cap is broken or missing

store between 20° to 25°C (68° to 77°F)

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

1-800-719-9260

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 at 20°-25°C (68°-77°F)
Questions or comments?

1-800-719-9260

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

hi

LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 61919-142(NDC: 45802-650)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
POVIDONE (UNII: FZ989GH94E)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize8mm
FlavorImprint Code L612
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 61919-142-077 in 1 BOTTLE; Type 0: Not a Combination Product09/13/202110/09/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07630109/13/202110/09/2023
Labeler - DirectRx (079254320)
Registrant - DirectRx (079254320)
Establishment
NameAddressID/FEIBusiness Operations
DirectRx079254320repack(61919-142)

Revised: 10/2023

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