Children's Allergy Relief

Children's Allergy Relief
SPL v2
SPL
SPL Set ID 1ab6a653-0b7c-69d7-e063-6394a90aacad
Route
ORAL
Published
Effective Date 2024-06-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loratadine (5 mg)
Inactive Ingredients
Aspartame Mannitol Stearic Acid Anhydrous Citric Acid Magnesium Stearate Sodium Starch Glycolate Type A Potato Microcrystalline Cellulose Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 106 Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
ANDA Active Since 2024-06-12

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
  • 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 tablets in 24 hours
children under 2 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

  • 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 20º to 25ºC (68º to 77ºF).
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

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

Section 51945-4

curist kids

Children's Allergy Relief

Loratadine Chewable Tablets USP, 5 mg

Antihistamine

Indoor and Outdoor Allergies

24 Hour Relief of Sneezing;

Runny Nose; Itchy, Watery Eyes;

Itchy Throat or Nose

Non-Drowsy*

60 CHEWABLE TABLETS

The chewable tablets are to be chewed before swallowing.

AGES 2+ YEARS

*When taken as directed. See Drug Facts Panel.

Grape Flavored

Dye-Free

curistrelief.com

Section 53413-1

Questions? 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 chewable tablet)

Loratadine USP, 5 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)
  • 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 tablets in 24 hours
children under 2 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

  • 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 20º to 25ºC (68º to 77ºF).
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

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

Section 51945-4 (51945-4)

curist kids

Children's Allergy Relief

Loratadine Chewable Tablets USP, 5 mg

Antihistamine

Indoor and Outdoor Allergies

24 Hour Relief of Sneezing;

Runny Nose; Itchy, Watery Eyes;

Itchy Throat or Nose

Non-Drowsy*

60 CHEWABLE TABLETS

The chewable tablets are to be chewed before swallowing.

AGES 2+ YEARS

*When taken as directed. See Drug Facts Panel.

Grape Flavored

Dye-Free

curistrelief.com

Section 53413-1 (53413-1)

Questions? 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 chewable tablet)

Loratadine USP, 5 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)