Children's Claritin ®

Children's Claritin ®
SPL v2
SPL
SPL Set ID 0371368b-dca6-af2f-e063-6394a90a0ac0
Route
ORAL
Published
Effective Date 2023-08-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loratadine (5 mg)
Inactive Ingredients
Aspartame Silicon Dioxide Magnesium Stearate Stearic Acid Anhydrous Citric Acid Sodium Starch Glycolate Type A Potato D&c Red No. 27 Fd&c Blue No. 2 Mannitol Cellulose, Microcrystalline Carminic Acid

Identifiers & Packaging

Pill Appearance
Imprint: C Shape: round Color: purple Color: pink Size: 10 mm Score: 1
Marketing Status
NDA Active Since 2006-08-23

Description

Loratadine 5 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Loratadine 5 mg

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

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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 53414-9

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

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:

  • grape flavor contains phenylalanine 1.4 mg per chewable tablet
  • bubblegum flavor contains phenylalanine 1.9 mg per chewable tablet

safety sealed: do not use if the individual blister unit imprinted with Children's Claritin® is open or torn

store between 20° to 25°C (68° to 77°F)

Inactive Ingredients

Grape chewable tablets

aspartame, citric acid anhydrous, colloidal silicon dioxide, D&C red No. 27 aluminum lake, FD&C blue No. 2 aluminum lake, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic aicd

Bubblegum chewable tablets

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

Questions Or Comments?

1-800-CLARITIN (1-800-252-7484)

Active Ingredient (in Each Tablet)

Loratadine 5 mg

Principal Display Panel 40 Chewable Tablet Blister Pack Carton

VARIETY PACK

ages

2 +

years



Non-Drowsy*

Children's

Claritin ®

Chewables

loratadine chewable tablets

5 mg/antihistamine



24 Hour

Non-Drowsy* Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

Indoor & Outdoor Allergies

20 Grape Flavored

20 Bubblegum Flavored

*When taken as directed. See Drug Facts Panel.

40 CHEWABLE TABLETS


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

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.

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 53414-9 (53414-9)

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

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:

  • grape flavor contains phenylalanine 1.4 mg per chewable tablet
  • bubblegum flavor contains phenylalanine 1.9 mg per chewable tablet

safety sealed: do not use if the individual blister unit imprinted with Children's Claritin® is open or torn

store between 20° to 25°C (68° to 77°F)

Inactive Ingredients (Inactive ingredients)

Grape chewable tablets

aspartame, citric acid anhydrous, colloidal silicon dioxide, D&C red No. 27 aluminum lake, FD&C blue No. 2 aluminum lake, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic aicd

Bubblegum chewable tablets

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

Questions Or Comments? (Questions or comments?)

1-800-CLARITIN (1-800-252-7484)

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

Loratadine 5 mg

Principal Display Panel 40 Chewable Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 40 Chewable Tablet Blister Pack Carton)

VARIETY PACK

ages

2 +

years



Non-Drowsy*

Children's

Claritin ®

Chewables

loratadine chewable tablets

5 mg/antihistamine



24 Hour

Non-Drowsy* Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

Indoor & Outdoor Allergies

20 Grape Flavored

20 Bubblegum Flavored

*When taken as directed. See Drug Facts Panel.

40 CHEWABLE TABLETS


Advanced Ingredient Data


Raw Label Data

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