LORATADINE- loratadine solution

Loratadine by

Drug Labeling and Warnings

Loratadine by is a Otc medication manufactured, distributed, or labeled by Camber Consumer Care Inc, Hetero Labs Limited Unit III. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

LORATADINE  
loratadine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69230-322
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	yellow (colorless to yellow)	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69230-322-12	1 in 1 CARTON	05/07/2021
1		120 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 69230-322-24	1 in 1 CARTON	05/07/2021
2		240 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA210409	05/07/2021

Labeler - Camber Consumer Care Inc (079539968)

Establishment
Name	Address	ID/FEI	Business Operations
Hetero Labs Limited Unit III		676162024	analysis(69230-322) , manufacture(69230-322)