Allergy relief

Manufacturer
NORTHEAST PHARMA | Geri-Care Pharmaceutical Corp
Effective date
2024-07-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:15:50

Label at a glance#

ProductAllergy relief
Active ingredientLORATADINE
Label structure8 sections

Indications and 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

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Loratadine, USP 10 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

call 1-800-540-3765

package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311372loratadine 10 MG 24HR Oral TabletPSN1
311372loratadine 10 MG Oral TabletSCD1
311372loratadine 10 MG 24 HR Oral TabletSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80136-658-06Allergy relief60 in 1 BOTTLETABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80136-658ALLERGY RELIEF (LORATADINE) TABLET [NORTHEAST PHARMA]11 package rows20240724_1deebe39-04f3-15da-e063-6394a90abb7b.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80136-65880136-658-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1deebeef-85b2-e027-e063-6294a90af5cb1deebe39-04f3-15da-e063-6394a90abb7b2024-07-23WarningsExact identifier
spl id: 1deebeef-85b2-e027-e063-6294a90af5cb
spl set id: 1deebe39-04f3-15da-e063-6394a90abb7b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.