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NDC 57896-0658-36 Allergy relief 10 mg/1 Details

Allergy relief 10 mg/1

Allergy relief is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Geri-Care Pharmaceutical Corp. The primary component is LORATADINE.

Product Information

NDC	57896-0658
Product ID	57896-658_ee1323ad-ce93-901e-e053-2995a90aba18
Associated GPIs	41550030000320
GCN Sequence Number	018698
GCN Sequence Number Description	loratadine TABLET 10 MG ORAL
HIC3	Z2Q
HIC3 Description	ANTIHISTAMINES - 2ND GENERATION
GCN	60563
HICL Sequence Number	007605
HICL Sequence Number Description	LORATADINE
Brand/Generic	Generic
Proprietary Name	Allergy relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Loratadine
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	10
Active Ingredient Units	mg/1
Substance Name	LORATADINE
Labeler Name	Geri-Care Pharmaceutical Corp
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA075209
Listing Certified Through	2024-12-31

Package

Package Images

NDC 57896-0658-36 (57896065836)

Pricing Information	N/A
NDC Package Code	57896-658-36
Billing NDC	57896065836
Package	365 TABLET in 1 BOTTLE (57896-658-36)
Marketing Start Date	2022-04-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b66f171a-7b95-b27a-e053-2a95a90a6009 Details

Active ingredient (in each tablet)

Loratadine, USP 10 mg

Purpose

Antihistamine

Uses

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

runny nose
sneezing
itching of the nose and throat
itchy, watery eyes

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

adults and children 12 years and over	1 tablet daily; not more than 1 tablet in 24 hours
children under 12 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other information

TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
store between 20° to 25°C (68° to 77°F)
protect from light

Inactive ingredients

lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions?

call 1-800-540-3765

package label

INGREDIENTS AND APPEARANCE

ALLERGY RELIEF

loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57896-658
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
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	439
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:57896-658-03	30 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2020
2	NDC:57896-658-09	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2020
3	NDC:57896-658-36	365 in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA075209	02/01/2020

Labeler - Geri-Care Pharmaceutical Corp (611196254)

Registrant - Geri-Care Pharmaceutical Corp (611196254)

Revised: 11/2022

Document Id: ee1323ad-ce93-901e-e053-2995a90aba18

Set id: b66f171a-7b95-b27a-e053-2a95a90a6009

Version: 2

Effective Time: 20221122