Loratadine Tablets Usp, 10mg/antihistamine

SPL v1

SPL

SPL Set ID baad51cd-daa0-4920-a6d5-2faaaaea7956

Route

ORAL

Published

Effective Date 2011-12-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Loratadine (10 mg)

Inactive Ingredients

Starch, Corn Lactose Monohydrate Magnesium Stearate

Identifiers & Packaging

Pill Appearance

Imprint: H;L20 Shape: round Color: white Size: 6 mm Score: 1

Marketing Status

ANDA Active Since 2023-07-28

Description

Active ingredient (in each tablet) Loratadine USP, 10 mg

Purpose

Antihistamine

How Supplied

Loratadine 10mg Tablet NDC 71335-2391-1: 20 Tablets in a BOTTLE NDC 71335-2391-2: 30 Tablets in a BOTTLE NDC 71335-2391-3: 60 Tablets in a BOTTLE NDC 71335-2391-4: 14 Tablets in a BOTTLE NDC 71335-2391-5: 10 Tablets in a BOTTLE NDC 71335-2391-6: 90 Tablets in a BOTTLE NDC 71335-2391-7: 28 Tablets in a BOTTLE NDC 71335-2391-8: 15 Tablets in a BOTTLE NDC 71335-2391-9: 100 Tablets in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Medication Information

Purpose

Antihistamine

How Supplied

Loratadine 10mg Tablet

NDC 71335-2391-1: 20 Tablets in a BOTTLE
NDC 71335-2391-2: 30 Tablets in a BOTTLE
NDC 71335-2391-3: 60 Tablets in a BOTTLE
NDC 71335-2391-4: 14 Tablets in a BOTTLE
NDC 71335-2391-5: 10 Tablets in a BOTTLE
NDC 71335-2391-6: 90 Tablets in a BOTTLE
NDC 71335-2391-7: 28 Tablets in a BOTTLE
NDC 71335-2391-8: 15 Tablets in a BOTTLE
NDC 71335-2391-9: 100 Tablets in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Description

Active ingredient (in each tablet) Loratadine USP, 10 mg

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

Section 51945-4

Loratadine 10mg Tablet

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

Do Not Use

if you have ever had an allergic reaction to this product or any of its ingredients.

Other Information

Bottles:

Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken
store between 20° to 25°C (68° to 77°F)

Blisters packs:

safety sealed: do not use if the individual blister unit imprinted with loratadine is open or torn
store between 20° to 25°C (68° to 77°F)
protect from excessive moisture

Active Ingredient(s)

Active ingredient (in each tablet)

Loratadine USP, 10 mg

Inactive Ingredients

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Questions Or Comments?

Call 1-888-588-1418

Pregnancy/breastfeeding

ask a health professional before use.

When Using This Product

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

Stop Use and Ask Doctor If

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

Keep Out of Reach of Children

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

Ask A Doctor Before Use If You Have

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

Structured Label Content

Use(s) (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

Section 51945-4 (51945-4)

Loratadine 10mg Tablet

Purpose (PURPOSE)

Antihistamine

Directions (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

Do Not Use (DO NOT USE)

if you have ever had an allergic reaction to this product or any of its ingredients.

How Supplied (HOW SUPPLIED)

Loratadine 10mg Tablet

NDC 71335-2391-1: 20 Tablets in a BOTTLE
NDC 71335-2391-2: 30 Tablets in a BOTTLE
NDC 71335-2391-3: 60 Tablets in a BOTTLE
NDC 71335-2391-4: 14 Tablets in a BOTTLE
NDC 71335-2391-5: 10 Tablets in a BOTTLE
NDC 71335-2391-6: 90 Tablets in a BOTTLE
NDC 71335-2391-7: 28 Tablets in a BOTTLE
NDC 71335-2391-8: 15 Tablets in a BOTTLE
NDC 71335-2391-9: 100 Tablets in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Other Information (OTHER INFORMATION)

Bottles:

Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken
store between 20° to 25°C (68° to 77°F)

Blisters packs:

safety sealed: do not use if the individual blister unit imprinted with loratadine is open or torn
store between 20° to 25°C (68° to 77°F)
protect from excessive moisture

Active Ingredient(s) (ACTIVE INGREDIENT(S))

Active ingredient (in each tablet)

Loratadine USP, 10 mg

Inactive Ingredients (INACTIVE INGREDIENTS)

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Call 1-888-588-1418

Pregnancy/breastfeeding (PREGNANCY/BREASTFEEDING)

ask a health professional before use.

When Using This Product (WHEN USING THIS PRODUCT)

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

Stop Use and Ask Doctor If (STOP USE AND ASK DOCTOR IF)

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

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

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

Ask A Doctor Before Use If You Have (ASK A DOCTOR BEFORE USE IF YOU HAVE)

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

Advanced Ingredient Data

[{"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LORATADINE", "unii": "7AJO3BO7QN", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"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", "51945-4": "Loratadine 10mg Tablet", "PURPOSE": "Antihistamine", "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", "DO NOT USE": "if you have ever had an allergic reaction to this product or any of its ingredients.", "HOW SUPPLIED": "Loratadine 10mg Tablet NDC 71335-2391-1: 20 Tablets in a BOTTLE NDC 71335-2391-2: 30 Tablets in a BOTTLE NDC 71335-2391-3: 60 Tablets in a BOTTLE NDC 71335-2391-4: 14 Tablets in a BOTTLE NDC 71335-2391-5: 10 Tablets in a BOTTLE NDC 71335-2391-6: 90 Tablets in a BOTTLE NDC 71335-2391-7: 28 Tablets in a BOTTLE NDC 71335-2391-8: 15 Tablets in a BOTTLE NDC 71335-2391-9: 100 Tablets in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504", "OTHER INFORMATION": "Bottles: Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken store between 20° to 25°C (68° to 77°F) Blisters packs: safety sealed: do not use if the individual blister unit imprinted with loratadine is open or torn store between 20° to 25°C (68° to 77°F) protect from excessive moisture", "ACTIVE INGREDIENT(S)": "Active ingredient (in each tablet) Loratadine USP, 10 mg", "INACTIVE INGREDIENTS": "corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch", "QUESTIONS OR COMMENTS?": "Call 1-888-588-1418", "PREGNANCY/BREASTFEEDING": "ask a health professional before use.", "WHEN USING THIS PRODUCT": "do not take more than directed. Taking more than directed may cause drowsiness.", "STOP USE AND ASK DOCTOR IF": "an allergic reaction to this product occurs. Seek medical help right away.", "KEEP OUT OF REACH OF CHILDREN": "In case of overdose, get medical help or contact a Poison Control Center right away.", "ASK A DOCTOR BEFORE USE IF YOU HAVE": "liver or kidney disease. Your doctor should determine if you need a different dose."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:06:20.884351 · Updated: 2026-03-14T23:09:03.764166