LORATADINE- loratadine tablet 
NuCare Pharmaceuticals,Inc.

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Active ingredient (in each tablet)

Loratadine 10mg

Purpose

Antihistamine

Uses

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

                -runny nose

                -sneezing               

                -itching of the nose and throat

                -itchy, watery eyes

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

adults and children
12 years and over
1 tablet daily; not more
than 1 tablet in 24 hours
children under 12
years of age
ask a doctor
consumers with liver
or kidney disease
ask a doctor

Other information

  • TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken
  • store between 2˚C and 30˚C (36˚F-86˚F)
  • product of Canada
  • protect from excessive moisture

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate,

magnesium stearate, microcrystalline cellulose

Questions?

call 1-800-540-3765

package label

pdp

LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-4077(NDC:57896-788)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize8mm
FlavorImprint Code LOR;10;APO
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68071-4077-77 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2017
2NDC:68071-4077-110 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07647101/01/200812/31/2019
Labeler - NuCare Pharmaceuticals,Inc. (010632300)
Establishment
NameAddressID/FEIBusiness Operations
NuCare Pharmaceuticals,Inc.010632300repack(68071-4077)

Revised: 5/2020
 
NuCare Pharmaceuticals,Inc.