Loratadine Tablets, 10 mg

Manufacturer
Granules Pharmaceuticals Inc.
Effective date
2025-05-05
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:00:34

Key Label Information

Active Ingredients And Purpose

ACTIVE INGREDIENT(S)

Loratadine 10 mg

PURPOSE

Antihistamine

Uses

USE(S)

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

WARNINGS

ASK A DOCTOR BEFORE USE IF

you have liver or kidney disease. Your doctor should determine if you need a different dose.

PREGNANCY/BREASTFEEDING

ask a health professional before use

Directions And Dosage

DIRECTIONS

adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Other Label Information

STORAGE

store between 20º to 25ºC (68º to 77ºF)

INACTIVE INGREDIENTS

Lactose monohydrate, magnesium stearate, sodium starch glycolate and starch maize pregelatinized

QUESTIONS OR COMMENTS

Contact 1-877-770-3183: Mon-Fri 8:00 AM EST to 5:00 PM PST.

PRINCIPAL DISPLAY PANEL-Container Label

NDC 70010-162-03 **Compare to the active ingredient in Claritin® NON-DROWSY* Loratadine Tablets, USP 10 mg Antihistamine Indoor & Outdoor Allergies Relief of: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose 30 Tablets *When taken as directed. See Drug Facts Panel.

NDC Codes

Ingredients

Complete SPL Sections

ACTIVE INGREDIENT(S)

OTC - ACTIVE INGREDIENT SECTION

Loratadine 10 mg

PURPOSE

OTC - PURPOSE SECTION

Antihistamine

USE(S)

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

ASK A DOCTOR BEFORE USE IF

OTC - ASK DOCTOR SECTION

you have liver or kidney disease. Your doctor should determine if you need a different dose.

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

do not take more than directed. Taking more than directed may cause drowsiness.

STOP USE AND ASK DOCTOR IF

OTC - STOP USE SECTION

an allergic reaction to this product occurs. Seek medical help right away.

PREGNANCY/BREASTFEEDING

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken

STORAGE

STORAGE AND HANDLING SECTION

store between 20º to 25ºC (68º to 77ºF)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Lactose monohydrate, magnesium stearate, sodium starch glycolate and starch maize pregelatinized

QUESTIONS OR COMMENTS

SPL UNCLASSIFIED SECTION

Contact 1-877-770-3183: Mon-Fri 8:00 AM EST to 5:00 PM PST.

PRINCIPAL DISPLAY PANEL-Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70010-162-03 **Compare to the active ingredient in Claritin® NON-DROWSY* Loratadine Tablets, USP 10 mg Antihistamine Indoor & Outdoor Allergies Relief of: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose 30 Tablets *When taken as directed. See Drug Facts Panel.

PRINCIPAL DISPLAY PANEL-Container Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70010-162-03 **Compare to the active ingredient in Claritin® NON-DROWSY* Loratadine Tablets, USP 10 mg Antihistamine Indoor & Outdoor Allergies Relief of: • Sneezing • Runny Nose • Itchy, Watery Eyes 30 Tablets • Itchy Throat or Nose *When taken as directed. See Drug Facts Panel.

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

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otcd15add0b-518c-3b6f-e053-2995a90a999e.xml2021-11-23
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