0c53cf0f-7682-a422-e063-6394a90ab764

SPL v2
SPL
SPL Set ID 0c53cf0f-7682-a422-e063-6394a90ab764
Route
oral
Published
Effective Date 2025-06-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
loratadine (10 mg)
Inactive Ingredients
sodium starch glycolate type a potato lactose monohydrate magnesium stearate starch, corn

Identifiers & Packaging

Pill Appearance
Imprint: G;10 Shape: round Color: white Size: 6 mm Score: 1
Marketing Status
anda active Since 2023-12-12
Description

Drug Facts

Medication Information

Warnings and Precautions

Warnings

Active Ingredient

Active ingredient (in each tablet)

Loratadine 10 mg

Indications and Usage

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
Dosage and Administration

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

Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other information

  • store between 20° and 25°C (68° and 77° F)
Section 50565-1

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)

Section 50566-9

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Section 50567-7

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Section 50569-3

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

Section 50570-1

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Section 51727-6

Inactive ingredients

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

Section 51945-4

curist

Allergy Relief

Loratadine Tablets USP, 10 mg

Antihistamine

Indoor and Outdoor Allergies

24 Hour Relief of Runny Nose;

Sneezing; Itchy, Watery Eyes;

Itchy Nose or Throat

Non-Drowsy*

500 Tablets

Section 53413-1

Questions or comments?

Call 1-844-243-1241 or email [email protected]

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose

Antihistamine

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

Active Ingredient (55106-9)

Active ingredient (in each tablet)

Loratadine 10 mg

Indications and Usage (34067-9)

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
Dosage and Administration (34068-7)

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

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information

  • store between 20° and 25°C (68° and 77° F)
Section 50565-1 (50565-1)

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)

Section 50566-9 (50566-9)

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Section 50567-7 (50567-7)

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Section 51727-6 (51727-6)

Inactive ingredients

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

Section 51945-4 (51945-4)

curist

Allergy Relief

Loratadine Tablets USP, 10 mg

Antihistamine

Indoor and Outdoor Allergies

24 Hour Relief of Runny Nose;

Sneezing; Itchy, Watery Eyes;

Itchy Nose or Throat

Non-Drowsy*

500 Tablets

Section 53413-1 (53413-1)

Questions or comments?

Call 1-844-243-1241 or email [email protected]

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Antihistamine

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:18.956545 · Updated: 2026-03-14T23:09:01.566522