Loratadine Tablets, 10 Mg

SPL v2

SPL

SPL Set ID a5d54183-06a9-4ae1-93b9-e9a2e03ad42b

Route

ORAL

Published

Effective Date 2025-06-16

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Loratadine (10 mg)

Inactive Ingredients

Lactose Monohydrate Starch, Corn Magnesium Stearate Sodium Starch Glycolate Type A Potato

Identifiers & Packaging

Pill Appearance

Imprint: G;10 Shape: round Color: white Size: 6 mm Score: 1

Marketing Status

ANDA Active Since 2020-01-01

Description

Loratadine 10 mg

Purpose

Antihistamine

How Supplied

Loratadine 10 mg: white (white to off white), round shaped and the imprint code is G;10. NDC 71335-2529-1: 20 Tablets in a BOTTLE NDC 71335-2529-2: 30 Tablets in a BOTTLE NDC 71335-2529-3: 60 Tablets in a BOTTLE NDC 71335-2529-4: 14 Tablets in a BOTTLE NDC 71335-2529-5: 10 Tablets in a BOTTLE NDC 71335-2529-6: 90 Tablets in a BOTTLE NDC 71335-2529-7: 28 Tablets in a BOTTLE NDC 71335-2529-8: 15 Tablets in a BOTTLE NDC 71335-2529-9: 100 Tablets in a BOTTLE Store between 20º to 25ºC (68º to 77ºF) Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Medication Information

Purpose

Antihistamine

How Supplied

Loratadine 10 mg: white (white to off white), round shaped and the imprint code is G;10.

NDC 71335-2529-1: 20 Tablets in a BOTTLE
NDC 71335-2529-2: 30 Tablets in a BOTTLE
NDC 71335-2529-3: 60 Tablets in a BOTTLE
NDC 71335-2529-4: 14 Tablets in a BOTTLE
NDC 71335-2529-5: 10 Tablets in a BOTTLE
NDC 71335-2529-6: 90 Tablets in a BOTTLE
NDC 71335-2529-7: 28 Tablets in a BOTTLE
NDC 71335-2529-8: 15 Tablets in a BOTTLE
NDC 71335-2529-9: 100 Tablets in a BOTTLE

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

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Description

Loratadine 10 mg

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

Section 51945-4

Loratadine 10mg Tablet

Storage

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

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

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

Active Ingredient(s)

Loratadine 10 mg

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.

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.

Ask A Doctor Before Use If

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

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.

Structured Label Content

Use(s) (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

Section 51945-4 (51945-4)

Loratadine 10mg Tablet

Purpose (PURPOSE)

Antihistamine

Storage (STORAGE)

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

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 10 mg: white (white to off white), round shaped and the imprint code is G;10.

NDC 71335-2529-1: 20 Tablets in a BOTTLE
NDC 71335-2529-2: 30 Tablets in a BOTTLE
NDC 71335-2529-3: 60 Tablets in a BOTTLE
NDC 71335-2529-4: 14 Tablets in a BOTTLE
NDC 71335-2529-5: 10 Tablets in a BOTTLE
NDC 71335-2529-6: 90 Tablets in a BOTTLE
NDC 71335-2529-7: 28 Tablets in a BOTTLE
NDC 71335-2529-8: 15 Tablets in a BOTTLE
NDC 71335-2529-9: 100 Tablets in a BOTTLE

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

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Other Information (OTHER INFORMATION)

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

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

Loratadine 10 mg

Inactive Ingredients (INACTIVE INGREDIENTS)

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

Questions Or Comments (QUESTIONS OR COMMENTS)

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

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.

Ask A Doctor Before Use If (ASK A DOCTOR BEFORE USE IF)

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

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.

Advanced Ingredient Data

[{"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "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  sneezing  itchy, water eyes  itching of the nose or throat", "51945-4": "Loratadine 10mg Tablet", "PURPOSE": "Antihistamine", "STORAGE": "store between 20º to 25ºC (68º to 77ºF)", "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 10 mg: white (white to off white), round shaped and the imprint code is G;10. NDC 71335-2529-1: 20 Tablets in a BOTTLE NDC 71335-2529-2: 30 Tablets in a BOTTLE NDC 71335-2529-3: 60 Tablets in a BOTTLE NDC 71335-2529-4: 14 Tablets in a BOTTLE NDC 71335-2529-5: 10 Tablets in a BOTTLE NDC 71335-2529-6: 90 Tablets in a BOTTLE NDC 71335-2529-7: 28 Tablets in a BOTTLE NDC 71335-2529-8: 15 Tablets in a BOTTLE NDC 71335-2529-9: 100 Tablets in a BOTTLE Store between 20º to 25ºC (68º to 77ºF) Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504", "OTHER INFORMATION": "Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken", "ACTIVE INGREDIENT(S)": "Loratadine 10 mg", "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.", "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.", "ASK A DOCTOR BEFORE USE IF": "you have liver or kidney disease. Your doctor should determine if you need a different dose.", "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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:19.643203 · Updated: 2026-03-14T23:09:01.566522