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NDC 69230-0322-12 Loratadine 5 mg/5mL Details

Loratadine 5 mg/5mL

Loratadine is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Camber Consumer Care Inc. The primary component is LORATADINE.

MedlinePlus Drug Summary

Loratadine is used to temporarily relieve the symptoms of hay fever (allergy to pollen, dust, or other substances in the air) and other allergies. These symptoms include sneezing, runny nose, and itchy eyes, nose, or throat. Loratadine is also used to treat itching and redness caused by hives. However, loratadine does not prevent hives or other allergic skin reactions. Loratadine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. Loratadine is also available in combination with pseudoephedrine (Sudafed, others). This monograph only includes information about the use of loratadine alone. If you are taking the loratadine and pseudoephedrine combination product, read the information on the package label or ask your doctor or pharmacist for more information.

Related Packages: 69230-0322-12
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Loratadine

Product Information

NDC	69230-0322
Product ID	69230-322_c35ffdd1-2e08-3a8d-e053-2a95a90aed41
Associated GPIs	41550030001220
GCN Sequence Number	018697
GCN Sequence Number Description	loratadine SOLUTION 5 MG/5 ML ORAL
HIC3	Z2Q
HIC3 Description	ANTIHISTAMINES - 2ND GENERATION
GCN	60562
HICL Sequence Number	007605
HICL Sequence Number Description	LORATADINE
Brand/Generic	Generic
Proprietary Name	Loratadine
Proprietary Name Suffix	n/a
Non-Proprietary Name	Loratadine
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	5
Active Ingredient Units	mg/5mL
Substance Name	LORATADINE
Labeler Name	Camber Consumer Care Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA210409
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69230-0322-12 (69230032212)

Pricing Information
NDC Package Code	69230-322-12
Billing NDC	69230032212
Package	1 BOTTLE in 1 CARTON (69230-322-12) / 120 mL in 1 BOTTLE
Marketing Start Date	2021-05-07
NDC Exclude Flag	N
Price Per Unit	0.04249
Pricing Unit	ML
Effective Date	2024-02-21
NDC Description	CHILD LORATADINE 5 MG/5 ML SOL
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 5
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 4dec6d48-78e0-48a4-9274-25f6cbf26a2c Details

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA210409	05/07/2021

Labeler - Camber Consumer Care Inc (079539968)

Name	Address	ID/FEI	Business Operations
Establishment
Hetero Labs Limited Unit III		676162024	analysis(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