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NDC 63868-0669-10 Allergy Relief 10 mg/1 Details

Allergy Relief 10 mg/1

Allergy Relief is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by CHAIN DRUG MARKETING ASSOCIATION 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: 63868-0669-10
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Loratadine

Product Information

NDC	63868-0669
Product ID	63868-669_7e9542d0-f6b9-7156-e053-2a91aa0a9a16
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Allergy Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	loratadine
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE, LIQUID FILLED
Route	ORAL
Active Ingredient Strength	10
Active Ingredient Units	mg/1
Substance Name	LORATADINE
Labeler Name	CHAIN DRUG MARKETING ASSOCIATION INC.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA206214
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63868-0669-10 (63868066910)

Pricing Information	N/A
NDC Package Code	63868-669-10
Billing NDC	63868066910
Package	1 BLISTER PACK in 1 CARTON (63868-669-10) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date	2018-09-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 18eaaeb7-1408-4621-bf88-1dc5cb06a9b3 Details

Active Ingredient (in each capsule)

Loratadine 10mg

Purpose

Antihistamine

Uses

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

• runny nose

• sneezing

• itchy, water eyes

• 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 (1-800-222-1222).

Directions

Adults and children6 years and over: 1 capsule daily; Not more than 1 capsule in 24 hours .

Children under 6 years of age: ask a doctor.

Consumers with Liver or kidney disease: ask a doctor.

Other information

• store between 20-25˚C (68-77˚F)

• protect from freezing

• retain carton for complete product information

Inactive ingredients

FD&C blue #1, gelatin, mono and diglyceride of caprilic/capric acid, pharmaceutical ink, polysorbate 80, povidone, purified water, sorbitol, sorbitan solution.

Questions or Comments?

1-844-705-4384

PRINCIPAL DISPLAY PANEL

Quality Choice®

NDC 63868-669-10

*Compare to the Active Ingredient in CLARITIN® Liqui-Gels®

Non-Drowsy†

Allergy Relief

Loratadine 10 mg | Antihistamine

Indoor & Outdoor Allergies

Relief of:

Sneezing | Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

24 Hour

†When taken as directed. See Drug Facts Panel.

10 Softgels**

**Liquid-Filled Capsules

INGREDIENTS AND APPEARANCE

ALLERGY RELIEF

loratadine capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63868-669
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
CAPRIC ACID (UNII: 4G9EDB6V73)
POVIDONE K30 (UNII: U725QWY32X)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	blue (Light Blue)	Score	no score
Shape	OVAL (oval shaped)	Size	3mm
Flavor		Imprint Code	21
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63868-669-10	1 in 1 CARTON	09/01/2018
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA206214	09/01/2018

Labeler - CHAIN DRUG MARKETING ASSOCIATION INC. (011920774)

Revised: 1/2019

Document Id: 7e9542d0-f6b9-7156-e053-2a91aa0a9a16

Set id: 18eaaeb7-1408-4621-bf88-1dc5cb06a9b3

Version: 1

Effective Time: 20190103