drug facts

drug facts

SPL v1

SPL

SPL Set ID 6e22813e-d8e7-4a91-b510-50fc3f028933

Route

oral

Published

Effective Date 2013-09-18

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

loratadine (10 mg)

Inactive Ingredients

starch, corn lactose monohydrate magnesium stearate

Identifiers & Packaging

Pill Appearance

Imprint: RX;526 Shape: round Color: white Size: 6 mm Score: 1

Marketing Status

anda active Since 2009-06-23

Purpose

Antihistamine

Description

Loratadine USP, 10 mg

Medication Information

Active Ingredient

Loratadine USP, 10 mg

Uses

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

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

Other Information

store between 20° and 25° C (68° and 77° F)
protect from excessive moisture
TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Inactive Ingredients

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Description

Loratadine USP, 10 mg

Principal Display Panel

SOUND BODY ^™

COMPARE TO THE ACTIVE INGREDIENT IN CLARITIN ^®†

Relief of: Sneezing, Itchy, Watery Eyes; Runny Nose; Itchy Throat or Nose

^* When taken as directed. See Drug Facts Panel.

Original Prescription Strength

NON-DROWSY ^*

Allergy Relief

Loratadine Tablets, USP 10 mg

Antihistamine

Indoor & Outdoor Allergies

10 Tablets

24 HOURS

ALLERGY RELIEF

Manufactured by: Ohm Laboratories Inc.

5104668/R0713

Questions?

Call 1-800-406-7984

Do Not Use

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

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 (1-800-222-1222).

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

Active Ingredient (ACTIVE INGREDIENT (IN EACH TABLET))

Loratadine USP, 10 mg

Uses (USES)

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

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

Other Information (OTHER INFORMATION)

store between 20° and 25° C (68° and 77° F)
protect from excessive moisture
TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Inactive Ingredients (INACTIVE INGREDIENTS)

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

SOUND BODY ^™

COMPARE TO THE ACTIVE INGREDIENT IN CLARITIN ^®†

Relief of: Sneezing, Itchy, Watery Eyes; Runny Nose; Itchy Throat or Nose

^* When taken as directed. See Drug Facts Panel.

Original Prescription Strength

NON-DROWSY ^*

Allergy Relief

Loratadine Tablets, USP 10 mg

Antihistamine

Indoor & Outdoor Allergies

10 Tablets

24 HOURS

ALLERGY RELIEF

Manufactured by: Ohm Laboratories Inc.

5104668/R0713

Questions? (QUESTIONS?)

Call 1-800-406-7984

Do Not Use (Do not use)

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

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 A Doctor If (Stop use and ask a doctor if)

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

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

Ask a health professional before use.

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 (1-800-222-1222).

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": "LORATADINE", "unii": "7AJO3BO7QN", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"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": ""}]

Raw Label Data

All Sections (JSON)

{"USES": "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", "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.", "QUESTIONS?": "Call 1-800-406-7984", "OTHER INFORMATION": "store between 20° and 25° C (68° and 77° F) protect from excessive moisture TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.", "INACTIVE INGREDIENTS": "Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch", "PRINCIPAL DISPLAY PANEL": "SOUND BODY ™ COMPARE TO THE ACTIVE INGREDIENT IN CLARITIN ®† Relief of: Sneezing, Itchy, Watery Eyes; Runny Nose; Itchy Throat or Nose * When taken as directed. See Drug Facts Panel. Original Prescription Strength NON-DROWSY * Allergy Relief Loratadine Tablets, USP 10 mg Antihistamine Indoor & Outdoor Allergies 10 Tablets 24 HOURS ALLERGY RELIEF Manufactured by: Ohm Laboratories Inc. 5104668/R0713", "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 (1-800-222-1222).", "ACTIVE INGREDIENT (IN EACH TABLET)": "Loratadine USP, 10 mg", "Ask a doctor before use if you have": "Liver or kidney disease. Your doctor should determine if you need a different dose."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:42.045222 · Updated: 2026-03-14T22:53:35.925326