dye-free children's loratadine chewable tablets usp, 5 mg

dye-free children's loratadine chewable tablets usp, 5 mg
SPL v2
SPL
SPL Set ID 0b29afdc-3b0f-3958-e063-6394a90a233a
Route
oral
Published
Effective Date 2021-01-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
loratadine (5 mg)
Inactive Ingredients
aspartame anhydrous citric acid silicon dioxide magnesium stearate mannitol microcrystalline cellulose sodium starch glycolate type a potato stearic acid

Identifiers & Packaging

Pill Appearance
Imprint: LC5 Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
anda active Since 2024-03-15

Purpose

Antihistamine

Description

Drug Facts


Medication Information

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
  • chew or crush tablets completely before swallowing.
adults and children 6 years and over chew 2 tablets daily; not more than 2 chewable tablets in 24 hours
children 2 to under 6 years of age chew 1 tablet daily; not more than 1 chewable tablet in 24 hours
children under 2 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
Other Information
  • phenylketonurics: contains phenylalanine 1.25 mg per tablet.
  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
  • store between 68° to 77°F (20° to 25°C).
Inactive Ingredients

aspartame, citric acid anhydrous, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

Description

Drug Facts

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 ifan 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 50570-1

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

Section 53414-9

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

Active Ingredient (in Each Chewable Tablet)

Loratadine USP, 5 mg

Principal Display Panel 5 Mg Tablet Blister Pack Carton

NDC 56062-921-20

FOR AGES 2+ YEARS

INDOOR & OUTDOOR ALLERGIES

children'sallergy

LORATADINE CHEWABLE TABLETS USP, 5 mg

ANTIHISTAMINE

Non-drowsy*

24-hour relief of:

• Sneezing • Runny nose

• Itchy, watery eyes • Itchy throat or nose

DYE FREE

ACTUAL

SIZE

20

CHEWABLE

TABLETS

GRAPE FLAVORED

*When taken as directed. See Drug Facts Panel

Compare to the active ingredient

of Children's Claritin ®Chewables


Structured Label Content

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
  • chew or crush tablets completely before swallowing.
adults and children 6 years and over chew 2 tablets daily; not more than 2 chewable tablets in 24 hours
children 2 to under 6 years of age chew 1 tablet daily; not more than 1 chewable tablet in 24 hours
children under 2 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
Other Information (Other information)
  • phenylketonurics: contains phenylalanine 1.25 mg per tablet.
  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
  • store between 68° to 77°F (20° to 25°C).
Inactive Ingredients (Inactive ingredients)

aspartame, citric acid anhydrous, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

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 ifan 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 50570-1 (50570-1)

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

Section 53414-9 (53414-9)

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

Active Ingredient (in Each Chewable Tablet) (Active ingredient (in each chewable tablet))

Loratadine USP, 5 mg

Principal Display Panel 5 Mg Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton)

NDC 56062-921-20

FOR AGES 2+ YEARS

INDOOR & OUTDOOR ALLERGIES

children'sallergy

LORATADINE CHEWABLE TABLETS USP, 5 mg

ANTIHISTAMINE

Non-drowsy*

24-hour relief of:

• Sneezing • Runny nose

• Itchy, watery eyes • Itchy throat or nose

DYE FREE

ACTUAL

SIZE

20

CHEWABLE

TABLETS

GRAPE FLAVORED

*When taken as directed. See Drug Facts Panel

Compare to the active ingredient

of Children's Claritin ®Chewables


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)