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

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

Section 55106-9

Active ingredient (in each tablet)

Loratadine 10 mg

Structured Label Content

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

Warnings and Precautions (34071-1)

Warnings

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

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Loratadine 10 mg

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