dye-free childrens loratadine

dye-free childrens loratadine
SPL v4
SPL
SPL Set ID ec24da65-23c1-419d-9603-08348d3b9cc7
Route
oral
Published
Effective Date 2024-04-05
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: 112 Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
anda active Since 2025-04-05

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 20° to 25°C (68° to 77°F).
Inactive Ingredients

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

Description

Drug Facts

Questions?

Call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-888-287-1915.

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 79903-330-30

equate™

Compare to

Children's Claritin®

Chewables active

ingredient*

childrens Non-Drowsy**

LORATADINE CHEWABLE

Tablets USP, 5mg

Antihistamine

24

HOURS

Dye-Free

AGES 2+ YEARS

Indoor & Outdoor Allergies

Bubble Gum Flavored

30 Chewable Tablets

The chewable tablets are to be chewed before swallowing.

Relief of:

  • Sneezing
  • Runny nose
  • Itchy, watery eyes
  • Itchy throat or nose

**When taken as directed.

See Drug Facts Panel.


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
  • 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 20° to 25°C (68° to 77°F).
Inactive Ingredients

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

Questions?

Call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-888-287-1915.

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 79903-330-30

equate™

Compare to

Children's Claritin®

Chewables active

ingredient*

childrens Non-Drowsy**

LORATADINE CHEWABLE

Tablets USP, 5mg

Antihistamine

24

HOURS

Dye-Free

AGES 2+ YEARS

Indoor & Outdoor Allergies

Bubble Gum Flavored

30 Chewable Tablets

The chewable tablets are to be chewed before swallowing.

Relief of:

  • Sneezing
  • Runny nose
  • Itchy, watery eyes
  • Itchy throat or nose

**When taken as directed.

See Drug Facts Panel.


Advanced Ingredient Data


Raw Label Data

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