sig - 1195a - 2025-0430

sig - 1195a - 2025-0430
SPL v4
SPL
SPL Set ID 8a1b3d40-8ec4-7e76-e053-2a95a90a84b1
Route
oral
Published
Effective Date 2025-04-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
loratadine (10 mg)
Inactive Ingredients
gelatin capric acid povidone k30 water sorbitol polysorbate 80 sorbitan fd&c blue no. 1

Identifiers & Packaging

Pill Appearance
Imprint: 21 Shape: oval Color: blue Size: 3 mm Score: 1
Marketing Status
anda active Since 2019-10-01

Purpose

Antihistamine

Description

Drug Facts


Medication Information

Warnings

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

Uses

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





Purpose

Antihistamine

Directions
adults and children 6 years and over 1 capsule daily; not more than 1 capsule 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 20-25˚C (68-77˚F)

• protect from freezing

• retain carton for complete information and warnings

Inactive Ingredients

FD&C Blue no. 1, gelatine, mono anddiglyceride of caprilic/capric acid, pharmaceutical ink, polysorbate 80,povidone, purified water, sorbitol, sorbitan solution.

Description

Drug Facts

Principal Display Panel

24 HR NON-DWOSY*

Compare to Claritin® Liqui-Gels® active ingredient†

NDC 21130-195-02

Signature Select®

ALLERGY RELIEF

SOFTGELS

LORATADINE 10mg / Antihistamine

Actual Size

Indoor and Outdoor Allergies

Non-Drowsy*

*When taken as directed. See Drug Facts Panel.

Relief of:

• Sneezing

• Runny Nose

• Itchy, Watery Eyes

• Itchy Throat or Nose

10 SOFTGELS** 

(**LIQUID-FILLED CAPSULES)

Section 42229-5

Drug Facts

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

Section 50569-3

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

Section 53414-9

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

Active Ingredient (in Each Capsule)


Loratadine  10mg






Structured Label Content

Warnings

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

Uses

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





Purpose

Antihistamine

Directions
adults and children 6 years and over 1 capsule daily; not more than 1 capsule 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 20-25˚C (68-77˚F)

• protect from freezing

• retain carton for complete information and warnings

Inactive Ingredients (Inactive ingredients)

FD&C Blue no. 1, gelatine, mono anddiglyceride of caprilic/capric acid, pharmaceutical ink, polysorbate 80,povidone, purified water, sorbitol, sorbitan solution.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

24 HR NON-DWOSY*

Compare to Claritin® Liqui-Gels® active ingredient†

NDC 21130-195-02

Signature Select®

ALLERGY RELIEF

SOFTGELS

LORATADINE 10mg / Antihistamine

Actual Size

Indoor and Outdoor Allergies

Non-Drowsy*

*When taken as directed. See Drug Facts Panel.

Relief of:

• Sneezing

• Runny Nose

• Itchy, Watery Eyes

• Itchy Throat or Nose

10 SOFTGELS** 

(**LIQUID-FILLED CAPSULES)

Section 42229-5 (42229-5)

Drug Facts

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

Section 50569-3 (50569-3)

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

Section 53414-9 (53414-9)

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

Active Ingredient (in Each Capsule) (Active Ingredient (in each capsule))


Loratadine  10mg






Advanced Ingredient Data


Raw Label Data

All Sections (JSON)