LORATADINE - loratadine tablet 
Camber Consumer Care Inc

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Loratadine tablets USP, 10mg/antihistamine

ACTIVE INGREDIENT(S)

Active ingredient (in each tablet)         
Loratadine USP, 10 mg


PURPOSE

Antihistamine

USE(S)

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.

ASK A DOCTOR OR PHARMACIST BEFORE USE IF

WHEN USING THIS PRODUCT

do not take more than directed. Taking more than directed may cause drowsiness.

STOP USE AND ASK DOCTOR IF

an allergic reaction to this product occurs. Seek medical help right away.

PREGNANCY/BREASTFEEDING


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 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

Bottles:  

Blisters packs:

INACTIVE INGREDIENTS


corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

QUESTIONS OR COMMENTS?

Call 1-888-588-1418

PRINCIPAL DISPLAY PANEL

Loratadine-tablets-USP-10mg-30's-carton

 

Loratadine-tablets-10mg-30s-carton

Loratadine-tablets-USP-10mg-30's-container

Loratadine-tablets-10mg-30s-container

Loratadine-tablets-USP-10mg-100's-carton

Loratadine-tablets-10mg-100s-carton

Loratadine-tablets-USP-10mg-100's-container

Loratadine-tablets-10mg-100s-container

Loratadine-tablets-USP-10mg-300's-carton

Loratadine-tablets-10mg-300s-carton

Loratadine-tablets-USP-10mg-300's-container

Loratadine-tablets-10mg-300s-container


LORATADINE  
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69230-323
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
Colorwhite (White to Off white) Scoreno score
ShapeROUNDSize6mm
FlavorImprint Code H;L20
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69230-323-301 in 1 CARTON07/28/2023
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:69230-323-311 in 1 CARTON07/28/2023
2108 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:69230-323-101000 in 1 BOTTLE; Type 0: Not a Combination Product07/28/2023
4NDC:69230-323-0110 in 1 CARTON07/28/2023
4NDC:69230-323-3210 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:69230-323-331 in 1 CARTON07/28/2023
5100 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:69230-323-341 in 1 CARTON07/28/2023
6300 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21171807/28/2023
Labeler - Camber Consumer Care Inc (079539968)
Establishment
NameAddressID/FEIBusiness Operations
Annora Pharma Private Limited650980746manufacture(69230-323)

Revised: 9/2023
Document Id: 04d9c5a8-1f42-f7c0-e063-6294a90a92ae
Set id: d57da4bd-af37-414a-a50c-e80d2bb28314
Version: 2
Effective Time: 20230908
 
Camber Consumer Care Inc