LORATADINE - loratadine solution 
Camber Consumer Care Inc

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Loratadine Oral Solution USP, 5mg/5 mL (OTC)

ACTIVE INGREDIENT(S)

(in each 5 mL teaspoonful)
Loratadine USP, 5mg


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.

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

 •use only with enclosed dosing cup


adults and children 6 years and over
2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours
children 2 to under 6 years of age
1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours
children under 2 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor


OTHER INFORMATION


• Sodium Free
• do not use if tape imprinted with 'SEALED FORYOUR PROTECTION' on top and bottom flaps of carton is not intact
• store between 20° to 25°C (68° to 77°F)


INACTIVE INGREDIENTS


ART grape flavor, edetate disodium dihydrate, glycerin, maltitol solution, monobasic sodium phosphate, non crystallizing sorbitol solution, phosphoric acid, propylene glycol, purified water, sodium benzoate and sucralose

QUESTIONS OR COMMENTS?

Call 1-888-588-1418

Distributed by:
Camber Consumer Care, Inc.
Piscataway, NJ 08854, USA.


STORAGE

PRINCIPAL DISPLAY PANEL

Loratadine Oral Solution USP, 5 mg/5mL 120 mL Carton Label

loratadine-os-carton

LORATADINE  
loratadine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69230-322
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
MALTITOL (UNII: D65DG142WK)  
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
SORBITOL (UNII: 506T60A25R)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Coloryellow (colorless to yellow) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69230-322-121 in 1 CARTON05/07/2021
1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:69230-322-241 in 1 CARTON05/07/2021
2240 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21040905/07/2021
Labeler - Camber Consumer Care Inc (079539968)
Establishment
NameAddressID/FEIBusiness Operations
Hetero Labs Limited Unit III676162024analysis(69230-322) , manufacture(69230-322)

Revised: 5/2021
Document Id: c35ffdd1-2e08-3a8d-e053-2a95a90aed41
Set id: 4dec6d48-78e0-48a4-9274-25f6cbf26a2c
Version: 1
Effective Time: 20210528
 
Camber Consumer Care Inc